Letters, Testimony & Comments

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
September 2 2014
August 25, 2014 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852...
August 26 2014
 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments...
July 31 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
July 22 2014
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft guidance issued by the Food and...
June 9 2014
BIO appreciates FDA’s efforts to further clarify labeling practices for products approved under the Accelerated Approval pathway....
May 27 2014
The importance of supporting biomedical research and innovation and the development of new therapies cannot be overstated. Today, we face...
May 20 2014
As with the FDA’s previous Guidance on this topic (2009 Guidance), BIO continues to support FDA‘s clarification of its views...
May 2 2014
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
April 25 2014
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
April 14 2014
BIO appreciates FDA’s efforts in convening its two day public workshop on January 6-7th entitled “Complex Issues in...
March 10 2014
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
March 4 2014
 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity...
February 3 2014
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) respectfully submits these comments in response to the Generic...
January 31 2014
 Dear Commissioner Hamburg and Director Burwell: On behalf of the member companies of Biotechnology Industry Organization (BIO),...
January 22 2014
 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity...
January 3 2014
December 16, 2013 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852...
December 18 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the...
November 27 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
November 18 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
November 5 2013
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the...
October 31 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 23 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 16 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 13 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 13 2013
GENERAL COMMENTS:   A. Comprehensive Approach to Pediatric Drug Development   BIO strongly supports a comprehensive...
September 13 2013
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
August 26 2013
Re: Docket No. FDA–2013–N–0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request...
August 5 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
July 29 2013
Re: Docket No. FDA–2013–N–050: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies; Notice of Public...
July 25 2013
Re: Docket No. FDA–2013–N–020: Center for Drug Evaluation and Research Medical Policy Council; Request for Comments...
July 16 2013
In general, the Draft Guidance is well written and provides very useful clarification of the implementation of FDA’s regulations on...
July 8 2013
Dear Dr. Conway: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on Section 220.6 of the National...
July 3 2013
Re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective...
June 25 2013
Re: Docket No. FDA–2013-D-0401: Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design...
June 24 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 8 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 7 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the “WHO Guidelines on the Quality, Safety...
April 19 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
April 12 2013
BIO supports the goals of the Affordable Care Act (ACA) in providing greater transparency regarding financial relationships with...
April 8 2013
Re: Docket No. FDA–2010-D-0643:  Draft Guidance for Industry on Electronic Source Data in Clinical Investigations;...
March 26 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
March 18 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
March 14 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
March 4 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday,...
March 1 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
March 1 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 27 2013
Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H....
February 21 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
February 19 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on...
February 4 2013
BIO respectfully submits both questions and comments for the National Health Surveillance Agency’s (ANVISA) consideration on the...
February 1 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
The Biotechnology Industry Organization (“BIO”) is pleased to submit the following comments in response to “Proposed...
December 21 2012
          The Biotechnology Industry Organization (BIO) is pleased to submit the following...
December 21 2012
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing with our...
December 18 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA or Agency) for the opportunity to submit...
November 30 2012
  Re:Docket No. FDA-2011-N-0090: Proposed Rule: Unique Device Identification System Dear Sir/Madam: The Biotechnology Industry...
November 7 2012
Dear Commissioner Hamburg: We are writing on behalf of the following higher education associations in consideration of issues raised...
November 5 2012
Re:  Patient-Centered Outcomes Research Institute (PCORI) Draft Methodology Report Dear Dr. Selby: The Biotechnology Industry...
September 14 2012
Re:  Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule; Proposed Rule [CMS-1590-P] Dear Acting...
September 4 2012
Dear Mr. Reed: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Draft Methodology for...
August 17 2012
Marilyn Tavenner Acting CMS Administrator Centers for Medicare and Medicaid Services     Dear Acting Administrator...
August 14 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
August 6 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
July 30 2012
 Dear Chairman Smith and Ranking Member Conyers: On behalf of the Biotechnology Industry Organization (BIO), I am writing to...
July 11 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
July 7 2012
Dear Sir/Madam: BIO thanks the FDA for the opportunity to provide comments on Modernizing the Regulation of Clinical Trials and...
May 31 2012
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express...
May 30 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA)...
May 21 2012
Re:      Proposed Project: Enrollment and Recertification of Entities in the 340B Drug Pricing Program (OMB No....
May 18 2012
BIO Public Statement Medicare Evidence Development & Coverage Advisory Committee Meeting Evidentiary Characteristics for Coverage...
May 16 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 14 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval...
May 11 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 11 2012
    Dear Chairman Upton and Ranking Member Waxman: On behalf of the Biotechnology Industry Organization (BIO), I am...
May 10 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 8 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 8 2012
      On behalf of the Biotechnology Industry Organization (BIO), I am writing to express support for the Food...
May 2 2012
Chairman Upton and Pitts, Ranking Member Waxman and Pallone, Members of the Committee, it is my privilege to provide testimony before you...
April 18 2012
Re: Request for Comments Regarding Evidentiary Characteristics of Coverage with Evidence Development Dear Ms. Ellis:   ...
April 16 2012
Re:      CMS-2345-P (Proposed Rule, Medicaid Program; Covered Outpatient Drugs) Dear Ms. Tavenner: The...
April 2 2012
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
March 27 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or the Agency) for the...
March 27 2012
Good morning Chairman Rehberg, Ranking Member DeLauro, Members of the Committee, ladies, and gentlemen. I am Scott Koenig, President and...
March 20 2012
RE: Patient-Centered Outcomes Research Institute (PCORI) Draft National Priorities and Research Agenda Dear Dr. Selby:   ...
March 15 2012
Re: Draft 2013 Call Letter Dear Mr. Blum and Mr. Spitalnic: The Biotechnology Industry Organization (BIO) appreciates this...
March 2 2012
  The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments...
February 29 2012
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to comment on...
February 29 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
February 21 2012
Centers for Medicare & Medicaid Services  Re:  Docket No. CMS-5060-P:  Proposed rule implementing Section 6002 of...
February 17 2012
Re:    Draft Framework for the National Plan to Address Alzheimer's Disease Dear Ms. Glied:     ...
February 8 2012
  Chairmen Upton and Pitts, and Ranking Members Waxman and Pallone, it is my privilege to provide testimony before this...
February 1 2012
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services...
January 31 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
January 17 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA...
January 9 2012
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on...
December 31 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
December 23 2011
Dear Sir/Madam: On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee...
December 16 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
December 2 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
November 28 2011
Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for...
November 23 2011
Given by Russell M. Medford, MD, PhD President and CEO, Salutria Pharmaceuticals, LLC BIO Board Standing Committee on Bioethics Co-...
November 16 2011
  Dear Dr. Menikoff:     The Biotechnology Industry Organization (BIO) thanks the Department of Health and Human...
October 26 2011
Thank you for the opportunity to present comments on behalf of the innovative biotechnology industry which is working to prevent, treat,...
October 25 2011
October 25, 2011 Secretary Kathleen Sebelius U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington,...
October 25 2011
October 25, 2011 Secretary Kathleen Sebelius U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington,...
October 25 2011
  On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment on the reauthorization of the...
October 24 2011
Dear Mr. Reed:             The Biotechnology Industry Organization (BIO) is...
October 20 2011
Re: Docket No. FDA–2011-D-0530: Draft Guidance for Industry and Food and Drug Administration Staff on MobileMedical Applications...
October 19 2011
  Re:  Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient...
September 30 2011
  Re: Docket No. FDA-2011-D-0239: Identifying the Center for Drug Evaluation and Research’s Science and Research Needs...
September 26 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
September 19 2011
RE:      Comments on Proposed Definition of PCORI  1.   Does the definition place appropriate...
September 2 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration...
September 1 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
September 1 2011
Re: Docket No. FDA-2010-D-0530:  Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves...
August 15 2011
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the core set of health quality measures for the...
August 9 2011
RE:     June 29, 2011 Memorandum on Proposed Changes to the Medicare Coverage Gap Discount Program – Low-Volume...
August 1 2011
  BIO fully supports the creation of an infectious disease standard by the Occupational Safety and Health Administration (OSHA) to...
July 29 2011
The Honorable Michael J. Rogers 133 Cannon HOB U.S. House of Representatives Washington, DC 20515 Dear Representative Rogers: On...
July 25 2011
BIO commends the FDA for prospectively seeking input from industry to ensure that the regulatory environment is supportive of the rapid...
July 23 2011
BIO’s comments addressed maters such as HRSA’s application of the exclusion, operational concerns arising from the proposed...
July 19 2011
Paul Hastings, testifying on behalf of BIO, discussed the importance of biotechnology in providing cures to diseases, and creating high-...
July 7 2011
BIO agrees with CMS that the proposed influenza vaccination standard will help increase vaccination coverage among patients, thereby...
July 5 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry...
June 15 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
Re: Medicare Program; Medicare Shared Saving Program: Accountable Care Organizations; Proposed Rule [CMS-1345-P] Dear Dr. Berwick:...
June 6 2011
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the...
May 31 2011
TESTIMONY OF PHYLLIS ARTHUR, SENIOR DIRECTOR FOR VACCINES, IMMUNOTHERAPEUTICS AND DIAGNOSTICS POLICY, BIOTECHNOLOGY INDUSTRY...
May 17 2011
Testimony of Phyllis Arthur, Senior Director for Vacines, Immunotherapeutics and Diagnostoics Policy Senate HELP Committee Good...
May 11 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry...
April 29 2011
The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine (IOM) for the opportunity to comment on the successes and...
April 28 2011
RE: Medicare Coverage Gap Discount Program Appeals Guidance The Biotechnology Industry Organization (BIO) appreciates this opportunity...
April 22 2011
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
April 19 2011
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic...
April 18 2011
Statement Opposing S.B. 2276 The Biotechnology Industry Organization (BIO) respectfully submits the following statement in opposition...
March 23 2011
Re: Draft 2012 Part D Call Letter Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) appreciates this...
March 4 2011
RE: Draft Update to Chapter 4 of the Medicare Managed Care Manual Dear Ms. Moon: The Biotechnology Industry Organization (BIO) is...
February 24 2011
Re: Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year...
January 11 2011
Re: Docket No. FDA-2010-D-0319 Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters:...
January 11 2011
Re: Docket No. FDA-2010-N-0477, Request for Comments on the Food and Drug Administration Approval Pathway for Biosimilar and...
December 23 2010
Re: Parallel Review of Medical Products [FDA-2010-N-0308] Dear Dr. Berwick and Dr. Hamburg: The Biotechnology Industry Organization (...
December 16 2010
Institute of Medicine Essential Health Benefits BIO Comments 1. What is your interpretation of the word “essential” in...
December 6 2010
Re: Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program [CMS-1345-...
December 3 2010
Re: Comments on Dispute Resolution Dear Ms. Taylor: The Biotechnology Industry Organization (“BIO”) appreciates this...
November 19 2010
Re: Comments on the Civil Monetary Penalties Dear Mr. Lang: The Biotechnology Industry Organization (BIO) appreciates this...
November 19 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials...
November 8 2010
Re: Docket No. Docket No. FDA-2010-N-0506, Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic...
November 1 2010
Re: Docket No. FDA-2010-D-0246: Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems Dear Sir...
November 1 2010
Re: Docket No. FDA–2010–N–0437, Development and Distribution of Patient Medication Information for Prescription Drugs...
October 29 2010
BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs."...
October 29 2010
Dear Governor Fortuño: In what is currently one of the worst economic recessions to be experienced in our lifetime, the life...
October 24 2010
Comments to the International Trade Administration: Vaccine production and additional planning for future possible pandemic influenza...
October 1 2010
Dear Ms. Maloy, As President and CEO of the Biotechnology Industry Organization (BIO) and on behalf of our more than 1,100...
September 30 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
Re: Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in...
September 23 2010
Re: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient...
September 17 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug...
September 7 2010
BIO is pleased that CMS proposes to reimburse all separately payable drugs and biologicals at average sales price (ASP) plus six percent...
August 31 2010
BIO agrees that prioritizing the select agents into stratified tiers based on an assessment of relative risk would be appropriate. We...
August 30 2010
BIO supports the draft Biennial Implementation Plan’s goal to rapidly develop and adopt countermeasures that mitigate health...
August 25 2010
BIO is concerned about problems in CMS methodology that continue to create instability in reimbursement for separately payable drugs and...
August 24 2010
Although BIO recognizes that preventing a significant cut in physician payment rates is largely within Congress' authority, we urge...
August 24 2010
BIO recommends that each grandfathered health plan disclose which insurance products it offers and cover preventive services and vaccines...
August 16 2010
BIO's comments to the FDA regarding LDT oversight.BIO represents companies that developed and manufacture LDTs consequently BIO...
August 15 2010
BIO recently submitted written comments to the FDA on the impact of Risk Evaluation and Mitigation Strategies (REMS) on the healthcare...
August 13 2010
BIO responded to the GAO request for feedback regarding the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act....
August 13 2010
BIO encourages ASPE to proceed with caution on the creation of an inventory and raises some methodological and structural considerations.
August 9 2010
BIO supports the view that a system of genetic test registration is necessary to provide stakeholders with information about the spectrum...
August 2 2010
BIO is concerned about CMS’ decision to open an NCA on a recently-approved therapy because it could establish a precedent that...
July 30 2010
BIO’s comments on FDA Transparency Task Force’s Draft Proposals for Public Comment Regarding Disclosure Policies. BIO agrees...
July 20 2010
BIO long has argued that actual and potential conflicts of interest in research should be identified, disclosed, and appropriately...
July 20 2010
BIO comments on the Medicare Coverage Gap Discount Program Draft Third Party Administrator Agreement (TPA Agreement) and the Draft Data...
July 16 2010
BIO submitted comments on the Annex 2, Revision 2, of the European GMP Guide: Manufacture of Biological Medicinal Products for Human Use...
July 15 2010
Optimizing the Security of Biological Select Agents and Toxins in The United States
July 2 2010
BIO urges that funds directed for pandemic influenza and the BioShield Special Reserve Fund not be rescinded so that they are available...
June 24 2010
Re: Medicare Coverage Gap Discount Program Model Manufacturer Agreement – [CMS-4151-NC] RIN 0938-AQ04 Dear Administrator Tavenner...
June 21 2010
Senate Finance Committee Member: On behalf of the Biotechnology Industry Organization (BIO) I am writing to state our opposition to...
June 7 2010
Re: FDA–2010– N–0218: Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the...
May 31 2010
BIO proposes that the guidance make it more clear which methods are being proposed, as early as possible and consistently throughout the...
May 27 2010
Re: FDA–2010–D–0090: Adaptive Design Clinical Trials for Drugs and Biologics Dear Sir/Madam: The Biotechnology...
May 27 2010
BIO supports the coverage gap discount program and believes that it will increase patient access to life-saving and life enhancing...
May 14 2010
In response to requests from its members, BIO has developed a formal BIO Policy Statement on Options for Increasing Access to Medicines...
May 1 2010
On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment in support of the reauthorization of the...
April 12 2010
Re: Draft 2011 Part D Call Letter Dear Acting Administrator Frizzera: The Biotechnology Industry Organization (BIO) appreciates this...
March 5 2010
March 1 2010
Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on...
November 23 2009
As Congress considered healthcare reform patient advocacy groups submitted a letter to Congressional leadership asking for their support...
November 19 2009
BIO Comments to CMS regarding Proposed Rule CMS-1413-P
August 31 2009
BIO Comments to CMS regarding Proposed Rule CMS-1414-P
August 31 2009
Re: Docket No. FDA-2009-D-0179, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological...
July 27 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
Re: Docket No. NIH-2008-0002 RIN 0925-AA53, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health...
July 7 2009
July 7, 2009 Jerry Moore NIH Regulations Officer NIH, Office of Management Assessment 6011 Executive Boulevard, Suite 601, MSC 7669...
July 7 2009
Re: Docket No. FDA- 2009-D-0132 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
July 1 2009
Re: Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List; Federal Register...
June 30 2009
Re: Docket Ref. EMEA/410/01-Rev. 4 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the European Medicines...
June 30 2009
Re: Docket No. NIH-2009-0002: Public Meeting on Expansion of the Clinical Trial Registry and Results Data Bank   Introduction...
June 22 2009
June 10 2009
Re: Docket No. FDA- 2009-D-0095. Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products –...
June 1 2009
Re: Draft National Institutes of Health Guidelines for Human Stem Cell Research (FR Doc. E9-9313) Dear Sir/Madam: The Biotechnology...
May 27 2009
Re: Docket No. FDA-2008-N-0038 Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
April 29 2009
Re: Docket No. FDA-2009-D-0006 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Dear Sir/Madam: The Biotechnology Industry...
April 20 2009
Re: Docket No. FDA-2009-D-0001, OC 2008299   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the...
April 16 2009
Re: Docket No. FDA-2008-D-0659. Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues...
April 16 2009
Re: Docket No. FDA-2009-D-0675, OC 20091. Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
April 13 2009
BIO is the largest trade organization to serve and represent the biotechnology industry in the United States and around the globe. BIO...
April 13 2009
Re: Docket No. NIH-2009-0002: Public Meeting on Expansion of the Clinical Trial Registry and Results Data Bank Introduction BIO...
April 13 2009
BIO’s Comments on the Provisional Appointments for the Institute of Medicine Committee on Comparative Effectiveness Research...
April 2 2009
Re: Docket No. FDA-2008-N-0612, OC 2008312. Sentinel Initiative: Structure, Function, and Scope; Public Workshop   Dear Sir/...
March 27 2009
House Bill 109-An Act Prohibiting the Use of Health Data for Marketing Purposes Senate Bill 17-An Act Relative to Data Mining Senate...
March 26 2009
Re: Docket No. FDA- 2009-D-2007. Animal Models - Essential Elements to Address Efficacy Under the Animal Rule Dear Sir/Madam: The...
March 23 2009
Re: CMS-4138-IFC4 (Medicare Program; Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary and Protected Classes...
March 17 2009
House Health and Government Operations Committee March 12, 2009 House Bill 1155-Prescription Confidentiality Act BIO opposes House...
March 12 2009
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on Senate Bill 1050. BIO is the largest trade...
March 2 2009
The Biotechnology Industry Organization (BIO) respectfully submits the following comments in opposition to Senate Bill 1049. An Act...
March 2 2009
Montana House Human Services Committee February 9, 2009 Statement of Opposition to House Bill HB394 Chair Becker and members of the...
February 9 2009
Re: FR Doc. E8-31195: HHS Action Plan to Prevent Healthcare-Associated Infections To whom it may concern: The Biotechnology Industry...
February 6 2009
Re: Docket No. FDA-2008-D-0559, Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability...
January 21 2009
BIO comments to the FDA
January 6 2009
Re: Docket No. FDA-2008-D-0514: End-of-Phase 2A Meetings Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the...
November 25 2008
Dear Sir or Madam, Thank you for the opportunity to provide comments on the Draft "Frequently Asked Questions: Licensure and...
November 20 2008
RE: Chapter 305 of the Acts of 2008, An Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health...
November 6 2008
Re: Docket No. FDA-2008-D-0386: International Conference on Harmonisation; Draft Guidance on E2F Development Safety Update Report;...
November 3 2008
Re: Draft Annex 11 “Computerised Systems” Dear Sir/Madam, The Biotechnology Industry Organization (BIO) appreciates the...
October 31 2008
Re: Section 102 Certificate Requirements Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Consumer Product...
October 31 2008
Re: Wholesale Distribution Senate Bill 759 Workgroup: Target Date for Implementation of Electronic Track and Trace Pedigree Technology...
October 24 2008
Re: Docket No. FDA-2008-D-0417: Draft Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings; Availability...
October 6 2008
Re: Emerging Health Care Competition and Consumer Issues – Comment, Project No. P083901 (Federal Register, September 3, 2008,...
October 1 2008
Re: Request for Comments regarding the July 30, 2008 CMS Posting of Potential National Coverage Decision Topics Dear Dr. Phurrough:...
September 26 2008
Re: OMB control number 0910-0616, Docket No. FDA-2008-N-0144, Agency Information Collection Activities; Submission for Office of...
September 26 2008
Re: BIO Comments Regarding Expansion of the ClinicalTrials.gov Database Dear Dr. Zarin and Dr. Morton: The Biotechnology Industry...
September 8 2008
Re: New Rule 560-12-1-.14 “Withdrawals from Inventory.” Proposed further changes to adopted Rule 560-12-1-.14, entitled...
September 5 2008
Re: CMS-1404-P (Medicare Program; Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Payment Rates;...
September 2 2008
  Re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009;...
August 29 2008
Re: FDA Docket 2006N-0467: Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy...
August 27 2008
Re: FDA Docket 2008N–0281: Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting Dear Sir/Madam:...
July 31 2008
Re: Veto Request of Puerto Rico House of Representatives Bill Number 506 Dear Governor Acevedo-Vila: On behalf of the Biotechnology...
July 30 2008
Subject: Department of Health, Chapter 83, Pharmaceutical Detailers, of Title 17, Business Occupations and Professions, of the District...
July 24 2008
Re: FDA Docket 2008N–0257: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment Dear Sir...
June 19 2008
Re: Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates [CMS-1390-P]...
June 13 2008
Re: Docket No. FDA–2008N–0234: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies...
June 6 2008
RE: Concept Paper on a Guideline on the Chemical and Pharmaceutical Quality Documentation Concerning Biological Investigational Medicinal...
May 30 2008
Re: Docket No. 2008N-0120: Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for...
May 19 2008
Re: Docket No. 2008N–0121: Technologies for Prescription Drug Identification, Validation, Track and Trace, or Authentication;...
May 19 2008
BIO's comments to CMS regarding the tracking sheet and prospective data collection requirements
May 9 2008
Dear Chairman Pallone and Ranking Member Deal: On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you...
May 2 2008
Re: Dear Manufacturer Letter Dated February 1, 2008 Dear General Granger: The Biotechnology Industry Organization (BIO) appreciates...
April 10 2008
Re: Medicare Program; Town Hall Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)—April 30,...
April 3 2008
Re: Adding Compendia for the Purposes of Making Medicare Coverage Determinations Dear Ms. Tillman: The Biotechnology Industry...
March 14 2008
BIO's testimony before the Advisory Panel on Ambulatory Payment Classifications regarding the policies the CMS has adopted and is...
March 7 2008
February 4 2008
Re: Comments on Draft CY 2009 Call Letter Dear Dr. Tudor: The Biotechnology Industry Organization (BIO) appreciates this opportunity to...
January 30 2008
Re: CMS-1392-FC (Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates) Dear...
January 28 2008
Re: CMS–10224 (Agency Information Collection Activities: Proposed Collection; Comment Request; HCPCS Level II Code Modification...
January 10 2008
Re: CMS-2238-P (Medicaid Program; Prescription Drugs) Dear Acting Administrator Weems: The Biotechnology Industry Organization (BIO)...
December 21 2007
BIO's comments on the SACGHS draft report
December 21 2007
BIO's comments on proposed changes to the 2010 HCPCS Level II Modification Process
December 10 2007
Re: Comments on the USP Draft Medicare Model Guidelines Dear Dr. Perfetto: The Biotechnology Industry Organization (BIO) appreciates...
December 6 2007
BIO's comments to AHRQ regarding the Guide to Conducting Comparative Effectiveness Reviews
November 7 2007
BIO's comments regarding the Effectiveness and Off-Label Use of Recombinant Factor VIIa
October 26 2007
BIO's comments to the FDA (96 KB PDF)
October 17 2007
The  Biotechnology Industry Organization (BIO) commends the WHO Intergovernmental Working Group on Public Health, Innovation and...
October 3 2007
BIO's comments on proposed changes to the 2009 HCPCS Level II Modification Process
September 18 2007
BIO's comments on the Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)
September 17 2007
BIO's comments to CMS regarding proposed changes
September 14 2007
September 11 2007
Comments on Notice Regarding the 340B Pricing Program; Children's Hospitals
September 7 2007
BIO's comments on
August 31 2007
Re: Docket No. 2006D-0347, Federal Register: July 26, 2007 (Volume 72, Pages 41081- 41083) Dear Sir/Madam, The following comments...
August 27 2007
BIO's comments on the CMS' Proposed Decision Memorandum.
August 17 2007
BIO letter to CMS
July 24 2007
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments to the Department of Health and Human...
July 13 2007
Re: Docket No. 2007N–0121: Use of Medication Guides to Distribute Drug Risk Information to Patients Dear Sir or Madam: The...
July 11 2007
Re: Proposed Decision Memorandum for Erythropoiesis Stimulating Agents (ESAs) for Non-Renal Disease Indications (CAG-00383N) Dear Dr....
June 13 2007
Dear Acting Administrator Norwalk: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers...
June 13 2007
June 6th, 2007 The Honorable Nancy Pelosi Office of the Speaker H-232, US Capitol Washington, DC 20515 Dear Speaker Pelosi: As...
June 6 2007
BIO's Comments on the SACGHS draft report.
June 1 2007
The Biotechnology Industry Organization (BIO) submits these comments on the European Medicines Agency’s (EMEA’s) draft...
May 23 2007
BIO's presentation to MCAC
May 10 2007
Dear Ms. English: We commend the National Vaccine Advisory Committee (NVAC) for addresssing the challenges of adolescent immunization....
May 7 2007
Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for the opportunity to testify before you today...
April 17 2007
Regarding their letter to Pharmaceutical Manufacturers on the definition of AMP used to calculate 340B ceiling prices.
April 16 2007
BIO letter to Senators Baucus and Grassley
April 11 2007
April 10th, 2007 The Honorable Harry Reid Majority Leader United States Senate Washington, DC 20510 Dear MR. Leader: As...
April 10 2007
BIO's Comments.
April 3 2007
Comments regarding purchasing by state and local governments through Federal Supply Schedules.
April 2 2007
RE: Inclusion of Prescription Drugs for Minimum Credible Coverage Dear Dr. Kingsdale: On behalf of the Biotechnology Industry...
March 15 2007
Comments on the HRSA Notice
March 13 2007
Comments on the HRSA Notice
March 13 2007
March 1 2007
Comments regarding the treatment of prescription drugs under the Medicaid Drug Rebate Program
February 20 2007
The Biotechnology Industry Organization (BIO) welcomes this opportunity to comment on the success of the Prescription Drug User Fee Act (...
February 16 2007
BIO's Comments on the Town Hall Meeting
February 6 2007
Survey Finds Private Sector Negotiations Provide Both Savings and Choice, Making Government Interference Unnecessary.
February 1 2007
BIO's testimony before the Advisory Panel on Ambulatory Payment Classification Groups
February 1 2007
Comments to agency's Proposed Rule regarding collection of and access to claims data under Medicare Part D.
December 18 2006
BIO's presentation to MCAC
December 13 2006
BIO's comments
December 8 2006
BIO's comments to CMS including list of recommended journals to be added
November 22 2006
BIO's letter to CMS Acting Administrator Leslie Norwalk
November 16 2006
November 11 2006
BIO's Comments
October 31 2006
BIO's Comments to CMS
October 10 2006
BIO's Comments to CMS
October 10 2006
Dear Dr. Coller, The Biotechnology Industry Organization (BIO) appreciates the opportunity yo provide comments to the Department of...
October 6 2006
From the Moran Company
October 6 2006
Comments to CMS on the draft.
September 26 2006
Comments to CMS
September 18 2006
BIO's comments regarding the CMS proposed notice on the five-year review of work relative value units (RVUs) and proposed changes to...
August 21 2006
The Biotechnology Industry Organization (BIO) appreciates this opportunity to testify before the Advisory Panel on Ambulatory Payment...
August 18 2006
BIO's comments on the CMS' Tracking Sheet regarding the development of a Clinical Research Policy (CRP) as a reconsideration of...
August 9 2006
On August 1, 2006 the Centers for Medicare and Medicaid Services (CMS) released the fiscal year (FY) 2007 hospital inpatient prospective...
August 8 2006
Statement of Peter Young, President and CEO of AlphaVax, Inc. on Behalf of BIO, the Biotechnology Industry Organization Presented...
April 6 2006
March 20 2006
BIO's comments regarding the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; Section 1013: Identification of...
March 1 2006
The Biotechnology Industry Organization (BIO) appreciates this opportunity to testify before the Advisory Panel on Ambulatory Payment...
March 1 2006
BIO's Comments on Authoritative Drug Compendia That May Be Used in Determining Medically Accepted Indications of Drugs and...
February 27 2006
BIO's Comments on the Centers for Medicare and Medicaid Servicesí interim final rule regarding exclusion of vendor purchases...
January 20 2006
January 13 2006
To United States Pharmacopeia
January 6 2006
BIO's Comments on the Centers for Medicare and Medicaid Services' final rule regarding revisions to payment policies under the...
December 23 2005
BIOís comments on Noridian Admistrative Services draft LCD regarding drugs and their covered diagnosis.
December 14 2005
BIO's comments on the Office of Inspector General's proposed Rule regarding new Safe Harbors for e-prescribing
December 13 2005
November 14 2005
November 14 2005
Notices of new systems of records: "Data Collection Secondary to Coverage Decision System," "Anti-Cancer Chemotherapy for...
October 28 2005
42 CFR 414.804 (CMS-10110)
October 14 2005
September 30 2005
Comments by BIO; CMS-1502-P (Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006)
September 30 2005
Comments by BIO; CMS-1501-P (Medicare Program; Proposed Changes to Hospital Outpatient Prospective Payment System and Calendar Year 2006...
September 16 2005
Comments by BIO; CMS-1325-IFC (Medicare Program; Competative Acquisition of Outpatient Drugs and Biologicals Under Part B)
September 6 2005
Comments by BIO; FDA Draft guidance; Docket 0062, Federal Register: May 10, 2005 (Volume 70, No. 89)
August 8 2005
Comments by BIO; FDA Docket 2005D-0122
July 13 2005
Docket No. 2005D-0004, Federal Register: January 26th, 2005 (Volume 70, Pages 3714-3715).
April 26 2005
Comments by BIO; CHMP/437/04
February 28 2005
Dr. Hambrick and members of the APC Advisory Panel, thank you for the opportunity to be here today. Unfortunately, Terry Ghio was unable...
February 23 2005
BIO's comments on the Proposed Bulletin for Good Guidance Practices released by the Office of Management and Budget (OMB).
January 9 2005
BIO's comments on the Centers for Medicare and Medicaid Servicesí final rule regarding revisions to the hospital outpatient...
January 9 2005
Docket No. 2004D-0440, Federal Register: October 4th, 2004 (Volume 69, Pages 59239-59240).
January 5 2005
As posted on CMS's Web site on December 3, 2004
December 23 2004
Docket No. 2004N-0355.
December 13 2004
Janna Tom, Assistant Director, Office of Technology Transfer, University of California; Vice President for Public Policy, Association of...
November 20 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
October 18 2004
Relating to CMS' proposed rule revisions from the Federal Register CMS-1427-P, August 16, 2004
October 8 2004
Federal Register CMS-1427-P, August 16, 2004
October 8 2004
HEARING ON PROJECT BIOSHIELD II OCTOBER 6, 2004 This statement is submitted by the Biotechnology Industry Organization (BIO), an...
October 6 2004
Federal Register CMS-4068-P, August 3, 2004
October 4 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
September 27 2004
Relating to CMS's proposed rule revisions
September 24 2004
Under the Medicare physician fee schedule.
September 24 2004
Comments to United States Pharmacopeia's draft Medicare Prescription Drug Benefit Model Guidelines
September 17 2004
September 8th, 2004 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,...
September 8 2004
The Biotechnology Industry Organization (BIO) appreciates this opportunity to testify about the hospital outpatient department...
September 2 2004
Good morning, my name is Jayson Slotnik and I am here on behalf of the Biotechnology Industry Organization (BIO), the trade association...
August 27 2004
Docket No. 2004S-0233, Federal Register: May 24, 2004.
August 23 2004
August 20th, 2004 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852...
August 20 2004
Joint letter with Plasma Protein Therapeutics Association (PPTA) concerning intravenous immune globulin ("IVIG")
August 10 2004
Docket No. 2004-N-0181, 69 Federal Register, 21839 (April 22, 2004)].
August 2 2004
Letter to Herb Kuhn, Director, Center for Medicare Management at the Centers for Medicare and Medicaid Services
July 26 2004
Background: On February 3, 2003, President Bush unveiled the details of Project BioShield, a comprehensive effort by the federal...
July 24 2004
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE JUDICIARY COMMITTEE OF THE UNITED STATES SENATE IMPORTATION OF...
July 14 2004
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.
July 2 2004
Development and Use of Risk Minimization Action Plans.
July 2 2004
Premarketing Risk Assessment.
July 2 2004
In response to §1013 of the Medicare Prescription Drug, Improvement, and Modernization Act.
July 1 2004
Dear Majority Leader Frist: We, the undersigned biotechnology executives, strongly oppose further efforts to legalize prescription drug...
June 7 2004
Re: Docket No. 2004N-0115 Request for Comment on Prescription Drug Importation Dear Dr. Carmona and Members of the HHS Task Force on...
June 1 2004
On behalf of the Biotechnology Industry Organization (BIO), please accept this letter in support of Senate Bill 74, a bill that would...
May 26 2004
The Honorable Judd Gregg Chairman Committee on Health, Education, Labor and Pensions United States Senate Washington...
May 24 2004
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE COMMITTEE ON HEALTH, EDUCATION, LABOR, & PENSIONS OF THE...
May 20 2004
Pharmacovigilance Planning (PvP).
May 19 2004
May 19 2004
On Conflict of Interest Policies
May 16 2004
May 11, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland...
May 11 2004
May 10, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland...
May 10 2004
April 14, 2004, 9:00 a.m. -5:00 p.m. Natcher Auditorium, Building 45, National Institutes of Health (NIH) 9000 Rockville Pike,...
April 14 2004
Providing Regulatory Submissions in Electronic Format ñ Content of Labeling.
April 5 2004
February 17, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
February 17 2004
February 6 2004
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
February 2 2004
February 2, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
February 2 2004
On Providing Regulatory Submissions in Electronic Format - General Considerations.
December 22 2003
CMC for Human Somatic Cell Therapy INDs
December 5 2003
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information.
December 4 2003
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
November 17 2003
November 5, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
November 5 2003
November 4, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
November 5 2003
November 3rd, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
November 3 2003
October 13, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
October 13 2003
The Honorable James Greenwood 2436 Rayburn House Office Building U.S. House of Representatives Washington, DC 20515 The Honorable...
September 17 2003
On Good Review Management Principles.
July 28 2003
The Honorable J. Dennis Hastert 235 Cannon House Office Building U.S. House of Representatives Washington DC 20510 Dear Speaker...
July 15 2003
Dear Chairman Thomas, Tauzin and Grassley: As conference begins on reconciling the differences between the House and Senate versions of...
June 24 2003
Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No...
June 17 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public...
May 29 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public...
May 29 2003
Dear Sir/Madam: The following comments supplement those presented by the Biotechnology Industry Organization (BIO) at FDA's public...
May 29 2003
J. Leighton Read, M.D. General Partner, Alloy Ventures Palo Alto, CA Testifying On Behalf Of The Biotechnology Industry Organization...
March 27 2003
The Honorable Mark B. McClellan Commissioner United States Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,...
February 14 2003
For Pharmaceutical Manufacturers
December 2 2002
The Honorable Tom Daschle 509 Hart Senate Office Building Washington DC 20510 Dear Senator Daschle: The Senate will very soon be...
November 18 2002
On October 17, 2002, Judge Henry H. Kennedy of the U.S. District Court for District of Columbia struck down FDA's "pediatric...
November 14 2002
Carl B. Feldbaum, BIO President Since its inception in the 1970's, the biotechnology industry's mission has been to improve and...
November 6 2002
September 13 2002
BIO members should immediately become familiar with provisions of the Public Health Security and Bioterrorism Response Act of 2002 (Pub....
August 8 2002
Letter from HHS Secretary Tommy Thompson
June 4 2002
Letter to Senator Ron Wyden (May 15, 2002).
May 15 2002
Dan Eramian, Vice President, Communications, Biotechnology Industry Organization (BIO) I don't know a better way to start a fight...
May 7 2002
Good morning, Mr. Chairman and Members of the Committee. My name is Dr. Charles Johnson. I am Associate Director of Specialty...
April 23 2002
Mr. Chairman and Members of the Subcommittee, I am Mary K. Pendergast, Executive Vice President for Government Affairs at Elan...
March 6 2002
BIO supports S. 1764, the Robert Stevens, Thomas Morris Jr., Joseph Curseen, Kathy Nguyen, Ottilie Lundgren, and Lisa Raines Biological and...
March 3 2002
Testimony of Dr. Una S. Ryan President and CEO, AVANT Immunotherapeutics, Inc. Before the Subcommittee on Science, Technology, and...
February 5 2002
FDA's Pediatric Rule Early Rule. In 1994 FDA issued a regulation requiring manufacturers of marketed drugs to survey existing...
January 8 2002
Good morning. My name is Michael Werner. I am Vice President for Bioethics for the Biotechnology Industry Organization (BIO). BIO...
December 7 2001
TESTIMONY OF STEPHEN G. SUDOVAR President and CEO EluSys Therapeutics, Inc. 10 Bloomfield Ave. Pine Brook, NJ 07058 973-808-0222 (...
October 23 2001
TESTIMONY U.S. House of Representatives Committee on Government Reform Subcommittee on National Security, Veterans Affairs, and...
October 23 2001
Executive Summary The Biotechnology Industry Organization (BIO) supports amendment of the current reexamination authority to enhance patent...
May 10 2001
The Biotechnology Industry Organization (BIO) is pleased to submit comments to the Food and Drug Administration (FDA) on the proposed...
April 18 2001
President-Elect George W. Bush Bush-Cheney Transition Headquarters 1800 G Street, N.W. Washington, DC 20270 Dear President-Elect...
January 17 2001
Good afternoon. My name is Michael Werner. I am bioethics counsel for the Biotechnology Industry Organization (BIO). BIO represents more...
March 10 2000
The Biotechnology Industry Organization (BIO) is encouraged that the Subcommittee on Health and the Environment of the House Commerce...
May 27 1999
Harold Shapiro, Ph.D. Chairman c/o E. Randolph Hull National Bioethics Advisory Commission 6100 Executive Blvd., Suite 5B01...
March 22 1999
EXECUTIVE SUMMARY Pluripotent stem cells research provides the hope of a new generation of therapeutics. Using cell transplants...
January 12 1999
Questions for the District of Columbia Board of Pharmacy for the drafting of SafeRx Frequently Asked Questions Document • Is there...
RE: Concerns with Senate Bill 2863 Dear Governor Patrick, On behalf of the more than 1,200 members of the Biotechnology Industry...
Assuring Vaccination of Children and Adolescents without Financial Barriers A Report of the National Vaccine Advisory Committee I....
Promoting Health and Preventing Disease: Childhood and Adult Vaccine Updates and Recommendations  
Draft Strategic National Vaccine Plan, 11/26/08 Preface: Letter from the Assistant Secretary for Health Given the importance of...
We are experiencing an unparalleled period of advancement and innovation in the life sciences globally that continues to transform our...
Time and again in our Nation's history, Americans have risen to meet -and to shape- moments of transition. This must be one of those...
October 14 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products—Considerations, Content, and Format.  BIO welcomes this Draft Guidance to ensure appropriate consistency in the format and content of product labeling for all prescription drug products approved by the Agency.  
September 2 2014
 The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Current Good Manufacturing Practices—Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act.”
August 26 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices (Draft Guidance).
July 31 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.”
July 22 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff.”
October 1 2014
Relationships between life sciences industry and physicians lead to stronger R&D collaboration and educate health care providers
September 22 2014
Washington, D.C. (September 22, 2014) – BIO President and CEO James Greenwood joined AdvaMed President and CEO Stephen Ubl and PhRMA President and CEO John Castellani in a letter to CMS Administrator Marilyn Tavenner highlighting ongoing concerns about a potential lack of necessary context around the Sunshine data release.  
April 7 2014
The EXPIRE Act would extend tax credits that expired at the end of 2013, including several of importance to the biotechnology industry.