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Letters, Testimony & Comments

BIO Comments on U.S. House of Representatives Committee on Energy and Commerce's White Paper Reviewing the Renewable Fuel Standard's (RFS) Agricultural Sector Impacts
May 23, 2013
April 29, 2013 The Honorable Fred Upton Chairman Energy and Commerce Committee U.S. House of Representatives 2125 Rayburn House Office Building Washington, DC ; 20515 The Honorable Henry A. Waxman Ranking Member Energy and Commerce...
Transatlantic Trade and Investment Partnership
May 16, 2013
Introduction The Biotechnology Industry Organization (BIO) appreciates the opportunity to respond to the Request for Comments issued by the U.S. Trade Representative on objectives to be pursued in the negotiation of a Transatlantic Trade and...
Broad Coalition Opposes Legislation to Require GE Labeling
May 9, 2013
May 8, 2013   We write to convey strong opposition to legislation recently introduced that would require special labels for food and beverages that contain ingredients derived from biotechnology or genetically engineered plants. There...
BIO's letter to FL Governor Scott Regarding Substitution of Biosimilar Medicines
May 8, 2013
The Honorable Rick Scott Office of the Governor State of Florida 400 S. Monroe St. Tallahassee, FL 32399-0001 Dear Governor Scott:  On behalf of the Biotechnology Industry Organization (“BIO”) and our more than 1,100...
PBRER: BIO Comments on Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
May 8, 2013
  Dear Sir/Madam:   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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic...
Benefit-Risk: BIO Comments on FDA's Prescription Drug User Fee Act V Benefit-Risk Plan
May 7, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the FDA Draft Plan on “Structured Approach to Benefit-Risk Assessment in Drug Regulatory...
Draft Environmental Assessment For GE Salmon: BIO Submits Comments to FDA
May 2, 2013
April 26, 2013 Docket No. FDA-2011-0899 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: FDA-2011-0899: Draft Environmental Assessment and Preliminary Finding of No...
BIO Comments on U.S. EPA's Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor
April 23, 2013
  April 22, 2013 Air and Radiation Docket                                ...
BIO Comments on U.S. EPA's Proposed Rule on the 2013 Renewable Fuel Standards
April 23, 2013
  April 5, 2013 Air and Radiation Docket and Information Center      Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC  20460 via email at: a-and-r-docket@...
BIO Comments on U.S. House of Representatives Committee on Energy and Commerce's White Paper Reviewing the Renewable Fuel Standard (RFS)
April 23, 2013
  April 5, 2013 The Honorable Fred Upton    Chairman                            ...
Recombinant DNA: BIO Comments on WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology
April 19, 2013
  The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the “WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology.” ...
Immunogenicity: BIO Comments on Draft Guidance on Immunogenicity Assessment for Therapeutic Protein Products
April 12, 2013
Dear Sir/Madam: 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 Immunogenicity Assessment for Therapeutic Protein...
Sunshine: BIO Files Comments on Estimated Burden of complying with Section 6002 of the Affordable Care Act (“the Sunshine Act”)
April 8, 2013
BIO supports the goals of the Affordable Care Act (ACA) in providing greater transparency regarding financial relationships with healthcare providers and we recognize the significant challenges that were presented in implementation of these ACA...
eSource: BIO Comments on FDA Draft Guidance on Electronic Source Data in Clinical Investigations
March 26, 2013
  Re: Docket No. FDA–2010-D-0643:  Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
BIO Comments on Peruvian Biologics and Biosimilars Regulations
March 21, 2013
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products. Peru is a growing market for biotechnology products and with the implementation of the US-Peru TPA, it promises...
BIO Testimony Regarding New Hampshire House Bill 1214
March 20, 2013
  Testimony of the Biotechnology Industry Organization (BIO) Hearing of the House Science, Technology & Energy Committee January 29, 2013 Regarding New Hampshire House Bill 1214: “AN ACT BANNING CORN-BASED ETHANOL AS AN...
BIO Testimony Regarding Maine Legislative Document 453
March 20, 2013
  Testimony of the Biotechnology Industry Organization (BIO) Hearing of the Joint Committee on Environment and Natural Resources March 20, 2013 Regarding Maine Legislative Document 453 “AN ACT TO PROHIBIT THE SALE OF...
Enrichment Strategies: BIO Submits Comments on FDA Draft Guidance on Enrichment Strategies for Clinical Trials
March 18, 2013
  Dear Sir/Madam:   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 Enrichment Strategies for Clinical...
BIO Submits Amicus Brief to Supreme Court in AMP v. Myriad Genetics
March 15, 2013
The Biotechnology Industry Organization (BIO) is the country’s largest biotechnology trade organization, representing over 1100 companies, academic institutions, and biotechnology centers in all 50 States and countries around the world...
Drug Shortages: BIO Comments on Drug Shortages Task Force and Strategic Plan
March 14, 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Food and Drug Administration Drug Shortages Task Force and...