Letters, Testimony & Comments

BIO commends the Brazilian Government for its efforts to revisit its policies with the goal of developing a legal framework that...
November 20 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
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
September 23 2013
Pennsylvania House of Representatives Health Committee Hearing House Bill 746 September 11, 2013 Good Morning: My name is Fritz...
September 17 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
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
July 29 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a...
July 10 2013
Biologics are complex medicines that are manufactured using living organisms.  Due to their size and complexity, biologics are...
July 8 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In general, the Draft Guidance is well written and provides very useful clarification of the implementation of FDA’s regulations on...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
Re: Docket No. FDA–2013-D-0401: Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design...
June 24 2013
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations...
June 19 2013
Countries across the globe are realizing the significant impact rare diseases have on their populations, and are responding by putting...
June 7 2013
The Honorable Rick Scott Office of the Governor State of Florida 400 S. Monroe St. Tallahassee, FL 32399-0001 Dear Governor Scott...
May 8 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
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
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 27 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
Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are...
January 24 2013
The Biotechnology Industry Organization (BIO) is the world’s largest biotechnology trade association. BIO represents more than 1,...
January 24 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
In December 2012, Virginia House Delegate John M. O'Bannon, III introduced the Interchangeable biosimilar biological products bill (H...
January 10 2013
  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
  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 Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
July 7 2012
The Biotechnology Industry Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state...
June 21 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 Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA)...
May 21 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 14 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 11 2012
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health...
March 1 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
  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
These comments are submitted by the Biotechnology Industry Organization (BIO) in response to the United States Department of Agriculture...
December 13 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 Dr. Menikoff:     The Biotechnology Industry Organization (BIO) thanks the Department of Health and Human...
October 26 2011
  On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment on the reauthorization of the...
October 24 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: 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 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 Honorable Michael J. Rogers 133 Cannon HOB U.S. House of Representatives Washington, DC 20515 Dear Representative Rogers: On...
July 25 2011
BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain relationships. It is important to...
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
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
Dear Chairman Frelinghuysen and Ranking Member Visclosky: On behalf of the Biotechnology Industry Organization (BIO), I am writing to...
May 17 2011
Dear Secretary Locke: On behalf of the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of...
May 13 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
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA April 28, 2011 The...
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
Committee on Environment and Public Works United States Senate Oversight Hearing on Domestic Renewable Fuels: From Ethanol to Advanced...
April 13 2011
Testimony of the Biotechnology Industry Organization (BIO) Hearing of the House Committee on Health, Education and Welfare April 13,...
April 13 2011
The Biotechnology Industry Organization ("BIO") is pleased to submit responses to question numbers 1,2, 4, 5, and 6 of the...
April 11 2011
Re: Comments on Section 6002 of the Affordable Care Act Dear Sir or Madam: BIO appreciates the opportunity to comment on the...
April 7 2011
Re: Docket No. FDA–2010–D–0643: Electronic Source Documentation in Clinical Investigations Dear Sir/Madam: The...
April 7 2011
E mail - ImprovingRegulations.SuggestionBox@epa.gov RE: Docket ID No. EPA-HQ-OA-2011-0157 (Improving Regulations: Pesticides) and EPA-...
April 4 2011
Re: Request for Comments on the Strategy for American Innovation Subject: Innovation Strategy RFI Email: competitiveness@doc.gov Dear...
April 1 2011
March 24, 2011 As our economy begins to improve, job creation remains a critical priority toward ensuring a broad, deep and sustained...
March 24 2011
Statement Opposing S.B. 2276 The Biotechnology Industry Organization (BIO) respectfully submits the following statement in opposition...
March 23 2011
Re: Docket No. FDA-2009-N-0247-0260: FDA Transparency Initiative: Improving Transparency to Regulated Industry Dear Sir/Madam: The...
March 8 2011
RE: Request for comments on Appendix 3 of the Chairperson’s Report on the November 15-16, 2010 Facilitated Work Session of the...
March 4 2011
Re: Draft Environmental Assessment: Use of Genetically Modified, Glyphosate-Tolerant Soybeans and Corn on National Wildlife Refuge Lands...
March 4 2011
Re: Draft 2012 Part D Call Letter Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) appreciates this...
March 4 2011
Re: Docket No. FDA–2011–N–0002: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of...
March 2 2011
HHS-OS-2010-002: Request for Information Regarding Value-based Insurance Design in Connection with Preventive Care Benefits The...
March 1 2011
Comments of Biotechnology Industry Organization on EPA’s Draft Report Biofuels and the Environment: First Triennial Report to...
February 28 2011
Patent Amendment (Human Genes and Biological Materials) Bill 2010 Submission to the Senate Legal and Constitutional Affairs Legislation...
February 25 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: Docket No. FDA–2010–N–0548: Good Laboratory Practice for Nonclinical Laboratory Studies Dear Sir/Madam: The...
February 22 2011
Re: Docket No. FDA–2010–D–0616 Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational...
February 14 2011
Re: Docket No. FDA–2010–D–0529 Draft Guidance for Industry on Qualification Process for Drug Development Tools;...
January 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-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...
December 28 2010
Dear Mr. Sunstein: The Biotechnology Industry Organization (BIO) wishes to express in the strongest possible terms its concerns...
December 23 2010
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
Re: IPR and Technology discussions at Cancún Climate Change Talks Dear Secretary Clinton and Ambassador Stern: At this very...
December 7 2010
Re: APHIS-2010-0047: Availability of an Environmental Assessment for Supplemental Request for Partial Deregulation of Sugar Beets...
December 6 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: Participation of Malaysia in the Trans-Pacific Partnership Trade Negotiations Dear Ms. Blue: The Biotechnology Industry...
November 22 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-N-0385) Food Labeling; Labeling of Food Made From AquAdvantage Salmon Dear Sir/Madam: The Biotechnology...
November 19 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
Dear President Obama: On behalf of the Biotechnology Industry Organization (BIO), Advanced Biofuels Association (ABFA), Algal Biomass...
October 21 2010
Dear Mr. Arny: U.S. farmers are concerned about the long-term sustainability of their farms and their place in society. For this reason...
October 18 2010
October 14, 2010 To: Members of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing of the Convention on Biological...
October 14 2010
Dear Ms. Smith: Thank you for taking the time to meet with BIO members on September 8. The information that you and Mike Gregoire...
October 6 2010
Dear Ms. Blue: This letter is submitted by the Biotechnology Industry Organization (BIO) in response to the request for public comments...
October 4 2010
      Product Launch Stewardship Introduction Through its advocacy efforts, BIO’s Food and Agriculture...
October 4 2010
Comments to the International Trade Administration: Vaccine production and additional planning for future possible pandemic influenza...
October 1 2010
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on India’s Department of Industrial...
September 29 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
Dear President Obama: We are writing to ask for your support to provide additional guidance to the Department of Energy’s (DOE)...
September 20 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’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 submitted comments on the Annex 2, Revision 2, of the European GMP Guide: Manufacture of Biological Medicinal Products for Human Use...
July 15 2010
Re: Medicare Coverage Gap Discount Program Model Manufacturer Agreement – [CMS-4151-NC] RIN 0938-AQ04 Dear Administrator Tavenner...
June 21 2010
Comments of Biotechnology Industry Organization on EPA’s Call for Information on Greenhouse Gas Emissions Associated with Bioenergy...
June 13 2010
Senate Finance Committee Member: On behalf of the Biotechnology Industry Organization (BIO) I am writing to state our opposition to...
June 7 2010
Dear Chairman Inouye and Ranking Member Cochran: As the Senate debates fiscal year 2011 federal funding, the undersigned organizations...
June 1 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
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
March 1 2010
Office of Medicine, Science, and Public Health Office of the Assistant Secretary for Preparedness and Response, FAO Jessica Tucker, Ph....
January 26 2010
Comments on the “Rule Requiring Use of Best Management Practices for Growing Crops to Minimize Cross Contamination” Dear...
December 14 2009
Dear Ms. Blue, This letter is submitted by the Biotechnology Industry Organization (BIO) in response to the request for public comment...
November 3 2009
Recommendations in the Secretary’s Advisory Committee on Genetics, Health and Society draft report on Gene Patenting and Licensing...
October 8 2009
RE: SEC Release No. 34-60611 Dear Deputy Secretary Harmon: On behalf of its members, the Biotechnology Industry Organization (“...
September 29 2009
Dear Secretary Vilsack: We are writing today to bring to your attention a court case that has the potential to negatively impact the...
September 9 2009
Re: Docket No. FDA- 2008-D-0253. Presenting Risk Information in Prescription Drug and Medical Device Promotion   Dear Sir/...
August 25 2009
Re: Docket No. FDA-2009-N-0247, Food and Drug Administration Transparency Task Force, Public Meeting Dear Sir/Madam: The...
August 5 2009
  VIEWS AND PROPOSALS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) AND THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF...
July 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
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
   Written Testimony of The Biotechnology Industry Organization (BIO) Before the United States House of Representatives...
April 30 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-0675, OC 20091. Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
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
Re: Docket No. FDA-2008-N-0612, OC 2008312. Sentinel Initiative: Structure, Function, and Scope; Public Workshop   Dear Sir/...
March 27 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
 Written Testimony of The Biotechnology Industry Organization (BIO) Before the United States Senate Committee on the...
March 10 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
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
Dear Chairman Cox: On behalf of its members, the Biotechnology Industry Organization (“BIO”) is pleased to provide comments...
October 27 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: 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: FDA Docket 2006N-0467: Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy...
August 27 2008
Re: DoH Call for Comments 08/2008 Dear Sir or Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
August 25 2008
Re: FDA Docket 2008N–0281: Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting Dear Sir/Madam:...
July 31 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: 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
Dear Chairman Pallone and Ranking Member Deal: On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you...
May 2 2008
February 4 2008
September 11 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
The Biotechnology Industry Organization (BIO) submits these comments on the European Medicines Agency’s (EMEA’s) draft...
May 23 2007
November 11 2006
March 20 2006
January 13 2006
To United States Pharmacopeia
January 6 2006
November 14 2005
Notices of new systems of records: "Data Collection Secondary to Coverage Decision System," "Anti-Cancer Chemotherapy for...
October 28 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
BIO's comments on the Proposed Bulletin for Good Guidance Practices released by the Office of Management and Budget (OMB).
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
Federal Register CMS-1427-P, August 16, 2004
October 8 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
Under the Medicare physician fee schedule.
September 24 2004
September 8th, 2004 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,...
September 8 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
In response to §1013 of the Medicare Prescription Drug, Improvement, and Modernization Act.
July 1 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
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
February 2, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland...
February 2 2004
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
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
Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No...
June 17 2003
For Pharmaceutical Manufacturers
December 2 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
September 13 2002
Letter from HHS Secretary Tommy Thompson
June 4 2002
FDA's Pediatric Rule Early Rule. In 1994 FDA issued a regulation requiring manufacturers of marketed drugs to survey existing...
January 8 2002
Re: Review of the Declaration of Helsinki   Dear Sir or Madam:   BIO appreciates the opportunity to comment on the World...
Dear Dr. Sim: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000...
The 2009 Government-Business Forum on Small Business Capital Formation recommended a permanent exemption for small companies from Section...
Dear Chairman Schapiro: The Biotechnology Industry Organization (BIO) thanks the Securities and Exchange Commission (SEC or Commission)...
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on the proposed regulations to implement...
February 3 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 Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”
November 20 2013
BIO welcomes the opportunity to provide the views of its members on facilitating access to genetic resources and traditional knowledge and the sharing of benefits from their use...
November 18 2013
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 Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products.”  
November 5 2013
BIO thanks FDA for releasing this Draft Guidance specifying the Data Universal Numbering System (DUNS) number as FDA’s preferred Unique Facility Identifier (UFI) system in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA) sections 701 and 702.  BIO supports FDA’s effort to have a single facility identification system in order to facilitate FDA’s activities that follow-on to registration which help secure patient and consumer safety, and we have several recommendations and requests for clarification on the proposal put forth in the Draft Guidance.
September 23 2013
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 Pre-Launch Activities Importation Requests.”  
March 25 2014
The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for signing legislation today designed to create a pathway for the substitution of interchangeable biologic medicines.
February 26 2014
Transparent communication important for Patients and Physicians
October 22 2013
Pending Legislation will Protect Indiana Citizens Utilizing Biologic Medications to Manage Chronic Diseases and other Unmet Medical Needs
September 5 2013
Jim Greenwood, President and CEO of BIO, issued the following statement on the California Senate's passage of Senate Bill 598.
June 7 2013
Oregon Governor John Kitzhaber signed legislation on Thursday, June 6 designed to address the regulatory issues related to the interchangeability of biological medicines.