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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
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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Testimony of BIO President & CEO John F. Crowley…
Chairman Cassidy, Ranking Member Sanders, and distinguished Members of the Committee:Thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO), which represents more than 1,000…
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House Ways and Means Ranking Member Sends Letter to USTR on Need for USMCA Enforcement
January 12, 2022
It has been eighteen months since the entry into force of the United States-Mexico-Canada Agreement (“USMCA”), which modernized our trilateral trading relationship in ways that advance the interests of all Americans. The Agreement not only…
Senate Finance Committee Leadership Sends Letter to USTR Ambassador Tai, Notes Mexico's Failure to Adhere to Biotech Commitments
January 12, 2022
The United States-Mexico-Canda Agreement has the potential to deliver tangible benefits for America's workers, farmers, and businesses by improving and strengthening the relationship between the United States and its two closest trading partners…
BIO Comments on Draft Guidance: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C
January 3, 2022
On Wednesday, December 29th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and…
BIO Comments on Draft Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
December 13, 2021
On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices…
BIO Comments on the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act
December 6, 2021
BIO is committed to enhancing clinical trial diversity as part of our BIOEquality Agenda published in the fall of 2020. During the pandemic we witnessed biopharmaceutical companies achieve increased clinical trial diversity through commitment and…
BIO Comments on FDA Draft Guidance, Benefit-Risk Assessment for New Drug and Biological Products
November 29, 2021
On Monday, November 29th, BIO submitted comments in response to a recent FDA draft guidance for industry clarifying how considerations about a drug’s benefits, risks, and risk management options factor into certain premarket and postmarket…
BIO comments on the Department for Digital, Culture, Media and Sport’s Public Consultation on reforms to the United Kingdom’s data protection regime
November 19, 2021
The Biotechnology Innovation Organization (BIO) welcomes the opportunity to provide comments on the Department for Digital, Culture, Media and Sport’s Public Consultation on reforms to the UK’s data protection regime.
BIO Submits Statement to House Ag Subcommittee Hearing on Trade Policy and Priorities
November 17, 2021
BIO applauds the Subcommittee for examining trade policy and priorities to support agricultural producers, promote innovation, protect the environment and enable agriculture to combat climate change. Because of bipartisan support, for over twenty…
BIO Submits Statement to House Ag Hearing on the Rural Economy
November 16, 2021
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture Subcommittee on Commodity Exchanges, Energy, and Credit hearing on A Look at the…
BIO Comments on ICH Draft Guidance S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
November 8, 2021
On Monday, November 8th, BIO submitted comments to the FDA’s draft guidance on Nonclinical Biodistribution Considerations for Gene Therapy Products. In the comment letter, BIO expressed appreciation for the Agency’s decision to put forth a draft…