Letters, Testimony & Comments

    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
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
  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
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
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 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
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the...
April 16 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 or Agency...
February 21 2012
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
  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...
September 19 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
Dear Senators Reid and McConnell and Representatives Boehner and Pelosi: We are deeply concerned about recent action in the U.S. House...
August 2 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
Paul Hastings, testifying on behalf of BIO, discussed the importance of biotechnology in providing cures to diseases, and creating high-...
July 7 2011
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
June 9 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–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: 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-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational...
December 28 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: (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. 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
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
Members of the Veterinary Medical Advisory Committee, My name is Dr. David Edwards, and I am the Director of Animal Biotechnology for...
September 20 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug...
September 7 2010
BIO's comments to the FDA regarding LDT oversight.BIO represents companies that developed and manufacture LDTs consequently BIO...
August 15 2010
BIO’s comments on FDA Transparency Task Force’s Draft Proposals for Public Comment Regarding Disclosure Policies. BIO agrees...
July 20 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: Docket No. FDA-2009-D-0179, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological...
July 27 2009
Re: Docket No. FDA- 2009-D-0095. Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products –...
June 1 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
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
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
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: Docket No. FDA–2008N–0234: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies...
June 6 2008
February 4 2008
BIO's comments to the FDA (96 KB PDF)
October 17 2007
September 11 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
Re: Docket No. 2007N–0121: Use of Medication Guides to Distribute Drug Risk Information to Patients Dear Sir or Madam: The...
July 11 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
The Biotechnology Industry Organization (BIO) welcomes this opportunity to comment on the success of the Prescription Drug User Fee Act (...
February 16 2007
November 11 2006
March 20 2006
January 13 2006
November 14 2005
Notices of new systems of records: "Data Collection Secondary to Coverage Decision System," "Anti-Cancer Chemotherapy for...
October 28 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; 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
The Biotechnology Industry Organization (“BIO”) is pleased to have the opportunity to comment on the Food and Drug...
March 27 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. 2004-N-0181, 69 Federal Register, 21839 (April 22, 2004)].
August 2 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
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
Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No...
June 17 2003
Mr. Chairman and Members of the Subcommittee, I am Mary K. Pendergast, Executive Vice President for Government Affairs at Elan...
March 6 2002
February 4 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on the proposal to create an alternative approval pathway for certain drugs intended to address unmet medical need, also referred to as a Special Medical Use (SMU) designation.
January 22 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for IRBs, Clinical Investigators, and Sponsors."
January 22 2013
BIO thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Development of Prioritized Therapeutic Data Standards (the Notice).”
August 6 2014
Survey responses will help inform Prescription Drug User Fee Act VI negotiations
January 30 2014
Patients Should Be Informed if Doctor's Prescription Changed
November 18 2013
BIO commends the Senate for approving H.R. 3204, the Drug Quality and Security Act.
July 29 2013
BIO released a statement in support of the FDA Safety Over Sequestration Act (H.R. 2725), which would exempt user fees, including those paid by BIO member companies, from the operation of sequestration.
February 9 2012
BIO President and CEO Jim Greenwood issued the following statement regarding the newly released U.S. Food and Drug Administration (FDA) guidance for the review and approval of biosimilars.