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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 Letter to Congressional Leadership on the…
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
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John F. Crowley's One-Year Anniversary Letter to…
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
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BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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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BIO Comments on Draft Guidance: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C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On Wednesday, December 29th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and…
BIO Comments on Draft Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products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On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices…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…
BIO Submits Comments to USDA for RFI on Climate-Smart Agriculture Practices
November 1, 2021
To meet the challenge of climate change, it is crucial to lead with science and U.S. innovation. We must incentivize the adoption of innovative, sustainable technologies and practices; and streamline and expedite regulatory pathways for breakthrough…