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Letters, Testimony & Comments

Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
February 19 2013
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
February 4 2013
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
January 22 2013
Unique Device Identification System Comments
  Re:Docket No. FDA-2011-N-0090: Proposed Rule: Unique Device Identification System Dear Sir/Madam: The Biotechnology Industry...
November 7 2012
REMS: BIO Comments on Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
July 6 2012
Risk Evaluation: BIO Comments on ICH's Proposed Guideline on E2C(R2) Periodic Benefit-Risk Evaluation Report
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 10 2012
Drug Safety: BIO Comments on FDA's Communication to the Public
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 7 2012
Drug Safety: BIO Comments on FDA's Draft Guidance on Classifying Significant Postmarket Drug Safety Issues
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the...
May 7 2012
BIO's Testimony to the Senate Health, Education, Labor, and Pensions Full Committee Hearing on the FY2012 FDA User Fee Agreements
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
Letter to the Texas Health and Human Services Commission Regarding Proposed Specialty Pharmacy Rule
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health...
March 1 2012
Safety Labeling: Establishing Timeframes for Implementation of Product Safety Labeling Changes
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency...
February 21 2012
Bar Code Technologies: BIO Comments on FDA's Bar Code Technologies for Drugs and Biological Products; Retrospective Review under Executive Order 13563
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA...
January 9 2012
Drug Shortages: BIO Comments on Center for Drug Evaluation and Research (CDER), Approach to Addressing Drug Shortage; Public Workshop; Request for Comments
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
December 23 2011
Transparency Initiative:Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to...
December 2 2011
Mobile Medical Applications: BIO Comments
Re: Docket No. FDA–2011-D-0530: Draft Guidance for Industry and Food and Drug Administration Staff on MobileMedical Applications...
October 19 2011
Sterility Testing: BIO's Comments on Amendments to Sterility Test Requirements for Biological Products
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit...
September 19 2011
ICH Q11: BIO Comments on International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances
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
Nanotechnology: BIO's Comments on Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
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
FDA Guidance Document: Transdermal Drug Delivery Systems
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
IRS: Implementation of Biopharmaceuticals Manufacturers Fee
September 30, 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
GAO: Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
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
Manufacturing Practices: Revisions to Europe’s cGMP Guide
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
Drug Importation: Statement of Opposition to S. 6210-A (Diaz)/A. 9207-A (Crespo) addressed to the Senate Finance Committee of New York State
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
Draft Guidance on Assessment of Abuse Potential of Drugs
March 29, 2010
March 29 2010
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
March 8, 2010
March 8 2010
Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)
February 1, 2010
February 1 2010
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
November 18, 2009
November 18 2009
The Draft Guidance for Industry on Good Importer Practices
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
Letter to Commissioner Bart L. Graham, Commissioner, Georgia Department of Revenue
September 5, 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
Proposed Revised Annex 2: Manufacture of Biological Medicinal Products for Human Use
March 14, 2008
March 14 2008
Comments on FDA's Draft Guidance for Industry on a Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practices Regulations
December 3, 2004
Docket No. 2004D-0443, CDER 20041115.
December 3 2004
BIO Testimony Against Importation
July 14, 2004
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE JUDICIARY COMMITTEE OF THE UNITED STATES SENATE IMPORTATION OF...
July 14 2004
BIO CEO Letter Opposing Importation
June 7, 2004
Dear Majority Leader Frist: We, the undersigned biotechnology executives, strongly oppose further efforts to legalize prescription drug...
June 7 2004
BIO Comments
June 1, 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
Before The Senate Committee On Health, Education, Labor, & Pensions
May 20, 2004
TESTIMONY OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION BEFORE THE COMMITTEE ON HEALTH, EDUCATION, LABOR, & PENSIONS OF THE...
May 20 2004
BIO Testimony to the HHS Importation Task Force
April 14, 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
Comments on FDA's Counterfeit Drug Task Force Interim Report
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
BIO Comments on FDA's Proposed Rule for Safety Reporting Requirements
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
Letter to US House of Representatives opposing HR 2427
July 21, 2003
July 21 2003
Letter in Opposition of H.R. 2427, to House Speaker Dennis Hastert
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
Letter from 53 Senators Opposed to Importation
June 24, 2003
Dear Chairman Thomas, Tauzin and Grassley: As conference begins on reconciling the differences between the House and Senate versions of...
June 24 2003
Letter to Mark McClellan regarding Personal Importation of Biological Products
February 14, 2003
The Honorable Mark B. McClellan Commissioner United States Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,...
February 14 2003
Dorgan Amendment, Letter opposing to Sen. Daschle
May 21, 2002
May 21 2002

Letters, Testimony & Comments

Electronic Submissions: BIO Comments on Providing Submissions in Electronic Format
February 19 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
SMU: BIO Statement on Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need
February 4 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide...
Data Standards: BIO Comments on Development of Prioritized Therapeutic Data
January 22 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
Unique Device Identification System Comments
November 7 2012
  Re:Docket No. FDA-2011-N-0090: Proposed Rule: Unique Device Identification System Dear Sir/Madam: The Biotechnology Industry...
REMS: BIO Comments on Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge
July 6 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the...
More Letters, Testimony & Comments →

Press Releases

IFPMA, BIO and WADA Advance Anti-Doping Collaboration with the Launch of 2 Fields 1 Goal Campaign
July 23 2012
Groups Issue Booklet to Help Biotechnology and Pharmaceutical Companies Identify Pipeline Medicines with Doping...
BIO Endorses “Declaration Against Doping in Sport"
June 28 2011
The Biotechnology Industry Organization (BIO) announced today its endorsement of the “Joint Declaration on...
Media Registration for the 2011 BIO International Convention Now Available Online
January 3 2011
WASHINGTON, D.C. (Monday, January 03, 2011) - The Biotechnology Industry Organization (BIO) announced today that...
BIO, Other Advanced Biofuels Organizations Ask Administration for Renewed Focus on Next Generation Biofuel Technologies
October 21 2010
WASHINGTON, D.C. (Thursday, October 21, 2010) - Federal biofuels policy should focus on helping companies...
New BIO Report Highlights Value of Biotechnology to Individuals and Society
May 4 2010
 WASHINGTON, D.C. (May 4, 2010) --  A new report issued by the Biotechnology Industry Organization...
More Press Releases →