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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
BIO Statement on Vaccines and Autism
Phyllis Arthur, EVP, Health Policy and Programs, “Vaccines are one of the most important and effective innovations for the defense of public health. They have saved millions of lives and drastically reduced or eliminated deadly and debilitating…
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BIO's Comments to CDC’s Advisory Committee on…
Re: Docket No. CDC-2025-0454; Advisory Committee on Immunization Practices (ACIP)The Biotechnology Innovation Organization (BIO) is appreciative of the opportunity to provide comments to the Advisory Committee on Immunization Practices (ACIP) in…
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CSBA Letter to Congressional Leaders Supporting…
Dear Majority Leader Thune, Minority Leader Schumer, Speaker Johnson, and Minority Leader Jeffries:The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory based non-profit trade associations, each of…
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BIO Comments on FDA Guidance: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
February 28, 2022
On Monday, February 28th, BIO submitted comments in response to the recent Food and Drug Administration (FDA) guidance for sponsors on designing or using an existing registry to support regulatory decision-making about a drug's effectiveness or…
BIO Letter to OMB on Animal Biotech and the Need to Allow Draft Guidance
February 16, 2022
The Biotechnology Innovation Organization (BIO) writes this letter to urge the Biden Administration to take specific and immediate steps towards modernizing U.S. oversight of animals derived from biotechnology, especially those intended for…
BIO Comments to EPA on Proposed RFS Rules
February 4, 2022
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Environmental Protection Agency’s (EPA) proposed Renewable Fuel Standard (RFS) Program: RFS Annual Rules (86 Fed. Reg. 72436).
BIO Comments on Data Standards for Drug and Biological Product Submissions Containing Real-World Data
February 4, 2022
On Friday, February 4th, BIO submitted comments on the Food & Drug Administration’s (FDA) recent draft guidance regarding the data standards for product submissions containing Real-World Data (RWD). In the comments submitted, BIO thanked the…
BIO Submits Comments on USTR's 2022 Special 301 Review
January 31, 2022
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public…
BIO Comments on WHO Considerations on Regulatory Convergence of Cell and Gene Therapy Products
January 27, 2022
On Thursday, January 27th, BIO submitted comments in response to the World Health Organization’s (WHO) recently published white paper on the regulation of Cell and Gene Therapy Products (CGTPs). First and foremost, BIO acknowledged that the…
BIO Comments on Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making
January 24, 2022
On Monday, January 24th, BIO submitted comments in response to the Food & Drug Administration’s (FDA) draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and…
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…