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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
ohn’s One-Year Anniversary Letter to BIO…
Dear Colleagues,This month marks my one-year anniversary as BIO’s CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
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BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request forComments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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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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Letter to Governor Deval Patrick
March 10, 2016
BIO letter to Governor Deval Patrick of Massachusetts regarding concerns about Senate Bill 2863.
BIO Testimony regarding Oregan Senate Bill 570
March 10, 2016
Testimony to the Oregon Senate Environment & Land Use Committee regarding The Oregon Genetically Engineered Pharmaceutical and Industrial Crop Act.
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…