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Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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Clinical Trials: ICTRP guidelines
March 10, 2016
BIO urges the ICTRP to focus on developing a procedure that would address the need to balance the incentive to innovate with the need to provide patients and health care providers with the information they need in order to assess the availability…
Clinical Trials: Review of the Declaration of Helsinki
March 10, 2016
BIO’s comments on the World Medical Association’s (WMA’s) Declaration of Helsinki.
Request for Comment Extension RE: Docket No. APHIS-2014-0054 – Environmental Impact Statement; Introduction of the Products of Biotechnology
February 18, 2016
We, the undersigned organizations, appreciate the opportunity to provide comment on APHIS’ Notice of Intent (NOI) to prepare an environmental impact statement in connection with potential changes to APHIS biotechnology regulations (7 CFR 340). Our…
BIO 2016 Special 301 Submission
February 8, 2016
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the 2016 Special 301 Submission. 
BIO Comments on FDA voluntary labeling of GE salmon
January 26, 2016
Food and Drug Administration Docket No. FDA-2015-D-4272; Food Labeling; Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry.
Congressional Black Caucus Letter to EPA on RFS RVO
October 30, 2015
As you finalize the proposed rules under the Renewable Fuel Standard, we respectfully urge you to not reduce the biofuels volume requirements. The RFS program has helped the environment, our economy, and has increased our confidence in renewable…
BIO Submits Comments Re: FDA Rare Diseases Guidance
October 22, 2015
RE: Docket No. FDA–2015–D–2818 Draft Guidance for Industry: Rare Diseases—Common Issues in Drug Development Dear Sir/Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback in response to the…
Rare Diseases: BIO Comments on Complex Issues for Rare Diseases
March 9, 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the docket regarding “Complex Issues in Developing Drug and Biologics Products for Rare Diseases.” Comments are…
FDA, Rare Diseases, Orphan Drug Act: Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases
May 31, 2010
BIO’s final comments on Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases.