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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
Testimony of John F. Crowley President and CEO,…
Chairman Griffith, Chairman Guthrie, Ranking Member DeGette, Ranking Member Pallone, and distinguished members of the subcommittee, thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO)…
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CSBA Letter to Congressional Leaders on PBM, PPRV…
Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…
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BIO's Comments on Advisory Committee on…
Re: Docket No. CDC-2025-0783; Advisory Committee on Immunization Practices (ACIP) MeetingDear Dr. Zadeh and Members of the ACIP:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide comments to the Advisory Committee…
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BIO Submits Comments to House Ways and Means on Expired Tax Provisions
March 14, 2018
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 Submits Comments Re: CY 2019 Medicare Advantage and Part D Call Letter
March 7, 2018
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 Comments on FDA Public Workshop on Patient-Focused Drug Development: Guidance 1
February 16, 2018
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BIO Comments on FDA Draft Guidance on Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
February 16, 2018
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…
Biofuel Sends Letter to EPA Administrator Pruitt on 2019 Cellulosic Volumes
February 15, 2018
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 Submits Comments on FDA Draft Guidance on Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
February 15, 2018
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 Comments on FDA Draft Guidance on Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
February 15, 2018
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…
BIO Comments on FDA Draft Guidance on Pediatric Rare Diseases – A Collaborative Approach for Drug Development Using Gaucher Disease as a Model
February 5, 2018
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 Comments on FDA Draft Guidance on Grandfathering Policy for Packages and Homogenous Cases of Product Without Product Identifier
January 26, 2018
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 Submits Comments Re: Medicare CY 2018 Part D Call Letter
January 25, 2018
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…