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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 Congressional Leadership on the…
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
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John F. Crowley's One-Year Anniversary Letter to…
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 for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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BIO Submits Comments on FDA Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document
December 11, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document. The draft guidance provides recommendations to applicants on drafting proposed Risk…
BIO Comments on Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration
December 7, 2017
BIO submitted comments on Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration (FDA). BIO is committed to promoting a regulatory environment that continues to support and incentivize the…
BIO Comments on "Considerations in Demonstrating Interchangeability with a Reference Product"
December 5, 2017
The Biotechnology Innovation Organization ("BIO") welcomes the opportunity to submit  comments on the Food and Drug Administration (FDA) draft guidance titled "Considerations in Demonstrating Interchangeability With a Reference Product" issued…
BIO Comments: Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access
December 5, 2017
Bio Comments on Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access (Docket No. FDA-2017-N-3615)
BIO Submits Comments Re: HHS Notice of Benefit and Payment Parameters for 2019
November 29, 2017
BIO submitted comments in response to the Department of Health and Human Services' Proposed Notice of Benefit and Payment Parameters for 2019. In its annual update of standards and requirements related to the exchanges and the health plans offered…
BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information
November 27, 2017
BIO submitted comments in response to the CMS Innovation Center New Direction Request for Information (RFI). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we have closely…
BIO Comments to FDA on “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments” (FDA-2017-N-5991; November 17, 2017)
November 21, 2017
Re: FDA-2017-N-5991: “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments”To whom it may concern:The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the…
BIO Comments on FDA Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity
November 21, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity. The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of…
Congressional Black Caucus and Congressional Hispanic Caucus Letter to EPA on RFS RVO
November 16, 2017
We are writing regarding the proposed 2018 Renewable Volume Obligation under the RFS. Rather than support continued growth in the lowest carbon types of biofuels under the statue, your proposal reduces the blending target for cellulosic biofuels and…
BIO Comments on Benefit-Risk Assessments in Drug Regulatory Decision-Making
November 13, 2017
BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making. The benefit-risk framework is an important advancement in FDA product regulation because it reflects and…