Letters, Testimony & Comments
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...
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 5 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
July 29 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
July 6 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 30 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA)...
May 20 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
May 13 2012
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 10 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
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
August 15, 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
July 25, 2011
The Honorable Michael J. Rogers
133 Cannon HOB
U.S. House of Representatives
Washington, DC 20515
Dear Representative Rogers:
On...
July 25 2011
July 25, 2011
BIO supports policies that emphasize disclosure of financial interests, rather than prohibiting certain relationships. It is important to...
July 25 2011
July 23, 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
June 9, 2011
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 2011
May 17, 2011
Dear Chairman Frelinghuysen and Ranking Member Visclosky:
On behalf of the Biotechnology Industry Organization (BIO), I am writing to...
May 17 2011
May 13, 2011
Dear Secretary Locke:
On behalf of the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of...
May 13 2011
May 11, 2011
Testimony of Phyllis Arthur, Senior Director for Vacines,
Immunotherapeutics and Diagnostoics Policy
Senate HELP Committee
Good...
May 11 2011
April 29, 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9]
Dear Mr. Commissioner:
The Biotechnology Industry...
April 29 2011
April 28, 2011
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA
April 28, 2011
The...
April 28 2011
April 22, 2011
RE: Medicare Coverage Gap Discount Program Appeals Guidance
The Biotechnology Industry Organization (BIO) appreciates this opportunity...
April 22 2011
April 19, 2011
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical...
April 19 2011
April 18, 2011
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic...
April 18 2011
April 13, 2011
Committee on Environment and Public Works
United States Senate
Oversight Hearing on Domestic Renewable Fuels: From Ethanol to Advanced...
April 13 2011
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
April 11, 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
April 7, 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
April 7, 2011
Re: Docket No. FDA–2010–D–0643: Electronic Source Documentation in Clinical Investigations
Dear Sir/Madam:
The...
April 7 2011
April 4, 2011
E mail - ImprovingRegulations.SuggestionBox@epa.gov
RE: Docket ID No. EPA-HQ-OA-2011-0157 (Improving Regulations: Pesticides) and EPA-...
April 4 2011
April 1, 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
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
March 23, 2011
Statement Opposing S.B. 2276
The Biotechnology Industry Organization (BIO) respectfully submits the following statement in opposition...
March 23 2011
March 8, 2011
Re: Docket No. FDA-2009-N-0247-0260: FDA Transparency Initiative: Improving Transparency to Regulated Industry
Dear Sir/Madam:
The...
March 8 2011
March 4, 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
March 4, 2011
Re: Draft Environmental Assessment: Use of Genetically Modified, Glyphosate-Tolerant Soybeans and Corn on National Wildlife Refuge Lands...
March 4 2011
March 4, 2011
Re: Draft 2012 Part D Call Letter
Dear Administrator Berwick:
The Biotechnology Industry Organization (BIO) appreciates this...
March 4 2011
March 2, 2011
Re: Docket No. FDA–2011–N–0002: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of...
March 2 2011
March 1, 2011
HHS-OS-2010-002: Request for Information Regarding Value-based Insurance Design in Connection with Preventive Care Benefits
The...
March 1 2011
February 28, 2011
Comments of Biotechnology Industry Organization on
EPA’s Draft Report
Biofuels and the Environment:
First Triennial Report to...
February 28 2011
February 25, 2011
Patent Amendment (Human Genes and Biological Materials) Bill 2010
Submission to the Senate Legal and Constitutional Affairs Legislation...
February 25 2011
February 24, 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
February 22, 2011
Re: Docket No. FDA–2010–N–0548: Good Laboratory Practice for Nonclinical Laboratory Studies
Dear Sir/Madam:
The...
February 22 2011
February 14, 2011
Re: Docket No. FDA–2010–D–0616 Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational...
February 14 2011
January 24, 2011
Re: Docket No. FDA–2010–D–0529 Draft Guidance for Industry on Qualification Process for Drug Development Tools;...
January 24 2011
January 11, 2011
Re: Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year...
January 11 2011
January 3, 2011
January 3 2011
December 28, 2010
Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...
December 28 2010
December 23, 2010
Dear Mr. Sunstein:
The Biotechnology Industry Organization (BIO) wishes to express in the strongest possible terms its concerns...
December 23 2010
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
December 16, 2010
Re: Parallel Review of Medical Products [FDA-2010-N-0308]
Dear Dr. Berwick and Dr. Hamburg:
The Biotechnology Industry Organization (...
December 16 2010
December 7, 2010
Re: IPR and Technology discussions at Cancún Climate Change Talks
Dear Secretary Clinton and Ambassador Stern:
At this very...
December 7 2010
December 6, 2010
Re: APHIS-2010-0047: Availability of an Environmental Assessment for Supplemental Request for Partial Deregulation of Sugar Beets...
December 6 2010
December 6, 2010
Institute of Medicine
Essential Health Benefits
BIO Comments
1. What is your interpretation of the word “essential” in...
December 6 2010
December 3, 2010
Re: Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program [CMS-1345-...
December 3 2010
November 22, 2010
RE: Participation of Malaysia in the Trans-Pacific Partnership Trade Negotiations
Dear Ms. Blue:
The Biotechnology Industry...
November 22 2010
November 19, 2010
Re: Comments on Dispute Resolution
Dear Ms. Taylor:
The Biotechnology Industry Organization (“BIO”) appreciates this...
November 19 2010
November 19, 2010
Re: Comments on the Civil Monetary Penalties
Dear Mr. Lang:
The Biotechnology Industry Organization (BIO) appreciates this...
November 19 2010
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
November 1, 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
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
October 29, 2010
Re: Docket No. FDA–2010–N–0437, Development and Distribution of Patient Medication Information for Prescription Drugs...
October 29 2010
October 21, 2010
Dear President Obama:
On behalf of the Biotechnology Industry Organization (BIO), Advanced Biofuels Association (ABFA), Algal Biomass...
October 21 2010
October 18, 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
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
October 6, 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
October 4, 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
October 4, 2010
Product Launch Stewardship
Introduction
Through its advocacy efforts, BIO’s Food and Agriculture...
October 4 2010
October 1, 2010
Comments to the International Trade Administration: Vaccine production and additional planning for future possible pandemic influenza...
October 1 2010
September 29, 2010
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on India’s Department of Industrial...
September 29 2010
September 23, 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
September 20, 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
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
July 20, 2010
BIO’s comments on FDA Transparency Task Force’s Draft Proposals for Public Comment Regarding Disclosure Policies. BIO agrees...
July 20 2010
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
July 15, 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
June 21, 2010
Re: Medicare Coverage Gap Discount Program Model Manufacturer Agreement – [CMS-4151-NC] RIN 0938-AQ04
Dear Administrator Tavenner...
June 21 2010
June 13, 2010
Comments of Biotechnology Industry Organization on EPA’s Call for Information on Greenhouse Gas Emissions Associated with Bioenergy...
June 13 2010
June 7, 2010
Senate Finance Committee Member:
On behalf of the Biotechnology Industry Organization (BIO) I am writing to state our opposition to...
June 7 2010
June 1, 2010
Dear Chairman Inouye and Ranking Member Cochran:
As the Senate debates fiscal year 2011 federal funding, the undersigned organizations...
June 1 2010
May 31, 2010
Re: FDA–2010– N–0218: Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the...
May 31 2010
May 27, 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
May 27, 2010
Re: FDA–2010–D–0090: Adaptive Design Clinical Trials for Drugs and Biologics
Dear Sir/Madam:
The Biotechnology...
May 27 2010
April 12, 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 15, 2010
March 15 2010
March 8, 2010
March 8 2010
February 2, 2010
February 2 2010
February 1, 2010
February 1 2010
January 26, 2010
Office of Medicine, Science, and Public Health
Office of the Assistant Secretary for Preparedness and Response,
FAO Jessica Tucker, Ph....
January 26 2010
December 30, 2009
December 30 2009
December 14, 2009
Comments on the “Rule Requiring Use of Best Management Practices for Growing Crops to Minimize Cross Contamination”
Dear...
December 14 2009
November 23, 2009
November 23 2009
November 18, 2009
November 18 2009
November 3, 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
October 13, 2009
October 13 2009
October 13, 2009
October 13 2009
October 8, 2009
Recommendations in the Secretary’s Advisory Committee on Genetics, Health and Society draft report on Gene Patenting and Licensing...
October 8 2009
September 29, 2009
RE: SEC Release No. 34-60611
Dear Deputy Secretary Harmon:
On behalf of its members, the Biotechnology Industry Organization (“...
September 29 2009
September 28, 2009
September 28 2009
September 9, 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
August 25, 2009
Re: Docket No. FDA- 2008-D-0253. Presenting Risk Information in Prescription
Drug and Medical Device Promotion
Dear Sir/...
August 25 2009
August 25, 2009
August 25 2009
August 5, 2009
Re: Docket No. FDA-2009-N-0247, Food and Drug Administration Transparency Task Force, Public Meeting
Dear Sir/Madam:
The...
August 5 2009
July 31, 2009
VIEWS AND PROPOSALS
OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) AND
THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF...
July 31 2009
July 27, 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
July 15, 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
July 13, 2009
RE: Comments in Response to Notice of Proposed Rulemaking: Department of Health and Human Services, 10-144, Chapter 275 – Reporting...
July 13 2009
July 7, 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 1, 2009
Re: Docket No. FDA- 2009-D-0132
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
July 1 2009
June 30, 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
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
June 22, 2009
Re: Docket No. NIH-2009-0002: Public Meeting on Expansion of the Clinical Trial Registry and Results Data Bank
Introduction...
June 22 2009
April 30, 2009
Written Testimony of
The Biotechnology Industry Organization (BIO)
Before the United States House of Representatives...
April 30 2009
April 20, 2009
Re: Docket No. FDA-2009-D-0006 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
Dear Sir/Madam:
The Biotechnology Industry...
April 20 2009
April 13, 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
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
March 27, 2009
Re: Docket No. FDA-2008-N-0612, OC 2008312. Sentinel Initiative: Structure,
Function, and Scope; Public Workshop
Dear Sir/...
March 27 2009
March 23, 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
March 10, 2009
Written Testimony of
The Biotechnology Industry Organization (BIO)
Before the United States Senate
Committee on the...
March 10 2009
January 21, 2009
Re: Docket No. FDA-2008-D-0559, Draft Guidance for Industry on Process Validation:
General Principles and Practices; Availability...
January 21 2009
January 6, 2009
BIO comments to the FDA
January 6 2009
November 25, 2008
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
November 3, 2008
Re: Docket No. FDA-2008-D-0386: International Conference on Harmonisation; Draft
Guidance on E2F Development Safety Update Report;...
November 3 2008
October 31, 2008
Re: Draft Annex 11 “Computerised Systems”
Dear Sir/Madam,
The Biotechnology Industry Organization (BIO) appreciates the...
October 31 2008
October 31, 2008
Re: Section 102 Certificate Requirements
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Consumer Product...
October 31 2008
October 27, 2008
Dear Chairman Cox:
On behalf of its members, the Biotechnology Industry Organization (“BIO”) is pleased to provide comments...
October 26 2008
October 6, 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
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
September 8, 2008
Re: BIO Comments Regarding Expansion of the ClinicalTrials.gov Database
Dear Dr. Zarin and Dr. Morton:
The Biotechnology Industry...
September 8 2008
August 27, 2008
Re: FDA Docket 2006N-0467: Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy...
August 27 2008
August 25, 2008
Re: DoH Call for Comments 08/2008
Dear Sir or Madam:
The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
August 25 2008
July 31, 2008
Re: FDA Docket 2008N–0281: Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting
Dear Sir/Madam:...
July 31 2008
June 19, 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
June 6, 2008
Re: Docket No. FDA–2008N–0234: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies...
June 6 2008
May 30, 2008
RE: Concept Paper on a Guideline on the Chemical and Pharmaceutical Quality Documentation Concerning Biological Investigational Medicinal...
May 30 2008
May 19, 2008
Re: Docket No. 2008N-0120: Standards for Standardized Numerical Identifier,
Validation, Track and Trace, and Authentication for...
May 19 2008
May 19, 2008
Re: Docket No. 2008N–0121: Technologies for Prescription Drug Identification,
Validation, Track and Trace, or Authentication;...
May 19 2008
May 12, 2008
May 12 2008
May 8, 2008
BIO's comments to the European Commission
May 8 2008
May 5, 2008
May 5 2008
May 2, 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
April 21, 2008
BIO's comments to the FDA
April 21 2008
March 17, 2008
March 17 2008
March 14, 2008
March 14 2008
March 13, 2008
BIO's views on issues relating to conflict of interest in research.
March 13 2008
February 22, 2008
February 22 2008
February 19, 2008
February 19 2008
January 30, 2008
January 30 2008
January 14, 2008
January 14 2008
December 17, 2007
December 17 2007
July 31, 2007
July 31 2007
July 31, 2007
July 31 2007
July 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
May 29, 2007
May 29 2007
May 23, 2007
The Biotechnology Industry Organization (BIO) submits these comments on the European Medicines Agency’s (EMEA’s) draft...
May 23 2007
April 9, 2007
April 9 2007
April 24, 2006
April 24 2006
February 8, 2006
February 8 2006
January 6, 2006
To United States Pharmacopeia
January 6 2006
November 21, 2005
November 21 2005
November 5, 2005
November 5 2005
October 31, 2005
October 31 2005
October 28, 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
September 16, 2005
Comments by BIO; CMS-1501-P (Medicare Program; Proposed Changes to Hospital Outpatient Prospective Payment System and Calendar Year 2006...
September 16 2005
September 6, 2005
Comments by BIO; CMS-1325-IFC (Medicare Program; Competative Acquisition of Outpatient Drugs and Biologicals Under Part B)
September 6 2005
August 8, 2005
Comments by BIO; FDA Draft guidance; Docket 0062, Federal Register: May 10, 2005 (Volume 70, No. 89)
August 8 2005
July 13, 2005
Comments by BIO; FDA Docket 2005D-0122
July 13 2005
June 17, 2005
June 17 2005
April 26, 2005
Docket No. 2005D-0004, Federal Register: January 26th, 2005 (Volume 70, Pages 3714-3715).
April 26 2005
April 11, 2005
April 11 2005
March 16, 2005
March 16 2005
February 28, 2005
Comments by BIO; CHMP/437/04
February 28 2005
January 14, 2005
Federal Register CMS-1427-FC, November 15, 2004
January 14 2005
January 12, 2005
January 12 2005
January 9, 2005
BIO's comments on the Proposed Bulletin for Good Guidance Practices released by the Office of Management and Budget (OMB).
January 9 2005
January 5, 2005
Docket No. 2004D-0440, Federal Register: October 4th, 2004 (Volume 69, Pages 59239-59240).
January 5 2005
December 27, 2004
CMS-1429-FC.
December 27 2004
December 23, 2004
As posted on CMS's Web site on December 3, 2004
December 23 2004
December 23, 2004
December 23 2004
December 13, 2004
Docket No. 2004N-0355.
December 13 2004
December 3, 2004
Docket No. 2004D-0443, CDER 20041115.
December 3 2004
November 18, 2004
CMS Draft Decision Memo CAG-00179N, November 1 2004
November 18 2004
October 8, 2004
Federal Register CMS-1427-P, August 16, 2004
October 8 2004
October 4, 2004
Federal Register CMS-4068-P, August 3, 2004
October 4 2004
September 27, 2004
Dear Sir/Madam:
The following comments are provided by the Biotechnology Industry Organization
(BIO). BIO represents more than 1,000...
September 27 2004
September 24, 2004
Under the Medicare physician fee schedule.
September 24 2004
September 8, 2004
September 8th, 2004
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville,...
September 8 2004
August 23, 2004
Docket No. 2004S-0233, Federal Register: May 24, 2004.
August 23 2004
August 20, 2004
August 20th, 2004
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland 20852...
August 20 2004
August 10, 2004
Joint letter with Plasma Protein Therapeutics Association (PPTA) concerning intravenous immune globulin ("IVIG")
August 10 2004
August 2, 2004
Docket No. 2004-N-0181, 69 Federal Register, 21839 (April 22, 2004)].
August 2 2004
July 26, 2004
Letter to Herb Kuhn, Director, Center for Medicare Management at the Centers for Medicare and Medicaid Services
July 26 2004
July 12, 2004
Federal Register CMS-1428-P, May 18, 2004
July 12 2004
July 1, 2004
In response to §1013 of the Medicare Prescription Drug, Improvement, and Modernization Act.
July 1 2004
June 7, 2004
Federal Register CMS-1380-IFC, April 6, 2004
June 7 2004
May 16, 2004
On Conflict of Interest Policies
May 16 2004
May 11, 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
May 10, 2004
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, Maryland...
May 10 2004
April 5, 2004
Providing Regulatory Submissions in Electronic Format ñ Content of Labeling.
April 5 2004
February 17, 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 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
December 5, 2003
CMC for Human Somatic Cell Therapy INDs
December 5 2003
December 4, 2003
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information.
December 4 2003
November 5, 2003
November 5, 2003
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, Maryland...
November 5 2003
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 3, 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
October 13, 2003
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, Maryland...
October 13 2003
September 17, 2003
The Honorable James Greenwood
2436 Rayburn House Office Building
U.S. House of Representatives
Washington, DC 20515
The Honorable...
September 17 2003
July 28, 2003
On Good Review Management Principles.
July 28 2003
July 15, 2003
The Honorable J. Dennis Hastert
235 Cannon House Office Building
U.S. House of Representatives
Washington DC 20510
Dear Speaker...
July 15 2003
June 17, 2003
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, Maryland 20852
Re: Docket No...
June 17 2003
March 28, 2003
March 28 2003
December 2, 2002
For Pharmaceutical Manufacturers
December 2 2002
November 14, 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
January 8, 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...
Key Documents
Letters, Testimony & Comments
February 27 2013
Dear Sir/Madam:
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration...
February 19 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
February 4 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
January 24 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,...
Press Releases
January 23 2013
Washington, D.C. (January 23, 2013) – The Biotechnology Industry Organization (BIO) announced that Ken...
October 9 2012
Any waiver of the RFS would have little to no effect on corn prices, but would certainly harm biofuel producers and...
February 9 2012
Patient Safety Must Remain Top Priority
Washington, D.C. (February 9, 2012) — Biotechnology Industry...
September 16 2011
Washington, D.C. (September 16, 2011) – Biotechnology Industry Organization (BIO) President and CEO Jim...
September 1 2011
WASHINGTON, D.C.(Sept. 1, 2011) – Research and development in synthetic biology is an evolution of...
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