Letters, Testimony & Comments

BIO appreciates the opportunity to comment on these proposed revisions. Patients living with rare diseases often experience significant unmet medical need due to the lack of knowledge about how these diseases are caused or inherited and their…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document. The draft guidance provides recommendations to applicants on drafting proposed Risk…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 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…

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Innovation Organization ("BIO") welcomes the opportunity to submit  comments on the Food and Drug Administration (FDA) draft guidance titled "Considerations in Demonstrating Interchangeability With a Reference Product" issued…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 on Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access (Docket No. FDA-2017-N-3615)

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 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…

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BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Statistical Approaches to Evaluate Analytical Similarity. The draft guidance provides important advice on the evaluation of analytical similarity for sponsors of…

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…