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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
Comments of the Biotechnology Innovation…
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
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BIO Comments to FWS on Use of GMOs on National…
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
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BIO Comments to the Minnesota Department of…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
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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On Monday, January 24th, BIO submitted comments in response to the Food & Drug Administration’s (FDA) draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and…
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…
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…
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.