Letters, Testimony & Comments

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products. BIO supports the FDA’s efforts to update and replace the 1997…

BIO submitted comments on the Food and Drug Administration’s (FDA) public meeting on Promoting the Use of Complex Innovative Designs in Clinical Trials. BIO supports the development and launch of this initiative. BIO shares the FDA’s goals for the…

BIO supports a seamless multi-year extension for the Second Generation Biofuel Producer Tax Credit; Special Depreciation Allowance for Second Generation Biofuel Plant Property; Biodiesel and Renewable Diesel Fuels Credit; and the …

BIO supports CMS’s commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment,…

BIO submitted comments after the Food and Drug Administration’s (FDA) public hearings on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input. BIO commends the FDA’s efforts to facilitate the use of…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases. The Best Pharmaceuticals for Children Act (BPCA) and the…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease. BIO welcomes the FDA’s efforts to provide clear, concise guidance on the regulatory…

As the U.S. EPA begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), a group of trade association advocates encourage the agency to take a renewed look at commercially ready cellulosic…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. This draft guidance provides important information on the expedited programs available…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Pediatric Rare Diseases – A Collaborative Approach for Drug Development Using Gaucher Disease as a Model.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