Letters, Testimony & Comments

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. This draft guidance provides important information on the expedited programs available…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Pediatric Rare Diseases – A Collaborative Approach for Drug Development Using Gaucher Disease as a Model. BIO appreciates the FDA’s intended goal with the guidance –…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier. BIO and its member companies are committed to meeting the…

BIO strongly supports CMS’s commitment to improving the quality of the Medicare Advantage (MA) and Part D programs. We consider it especially important to focus on policies that impact access to prescription drugs and biologicals for Medicare…

BIO supports CMS’s efforts to make changes to the Medicare Advantage, Medicare Fee-for-Service and the Part D Prescription Drug Benefit Programs in a manner that improves overall healthcare quality, while not compromising access to the most…

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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Format and Content of a Risk Evaluation and Mitigation Strategy Document. The draft guidance provides recommendations to applicants on drafting proposed Risk…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Innovation Organization ("BIO") welcomes the opportunity to submit  comments on the Food and Drug Administration (FDA) draft guidance titled "Considerations in Demonstrating Interchangeability With a Reference Product" issued…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)