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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 HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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BIO Comments on FDA’s Public Workshop on Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation
December 23, 2020
On Wednesday, December 23rd, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s October 2020 public workshop titled, “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing…
BIO Submits Comments on Final EPA PIP rule
December 9, 2020
The Biotechnology Innovation Organization (BIO) submits these comments in response to the U.S. Environmental Protection Agency’s (EPA) request for public input on proposed revisions to regulations related to the oversight of certain plant…
BIO Submits Testimony to Senate Hearing on Ag Research and Securing the Food Supply
December 3, 2020
Innovative breakthroughs can secure our nation’s food supply by reducing greenhouse gas emissions throughout agricultural supply chains; strengthening producers’ resiliency to climate change while increasing production; and tackling hunger and…
BIO Comments on FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins
November 9, 2020
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a…
BIO Submits Comments on NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products
November 2, 2020
On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period…
Patient Reported Outcomes: BIO Comments on FDA Draft Guidance Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
October 30, 2020
October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology…
BIO Sends Letter to HHS Secretary Alex Azar Urging him to Release Pending Vaccine Clinical Trial Guidance
October 2, 2020
  On behalf of the scientists and researchers the Biotechnology Innovation Organization (BIO) represents, I am writing to request that you publicly release all new guidance developed by the Food and Drug Administration (FDA) concerning…
Right to Try: BIO Comments on Annual Summary Reporting Requirements Under the Right to Try Act, Proposed Rule
September 28, 2020
September 22, 2020 Re: Docket No. FDA-2019-N-5553: Annual Summary Reporting Requirements Under the Right to Try Act, Proposed Rule Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or…
Pediatrics: BIO Comments on FDA Draft Guidance Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format
September 28, 2020
September 27, 2020 Re: Docket No. FDA-2014-D-1551:  FDA Draft Guidance, Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products – Content and Format. Dear Sir/Madam: The…
BIO Signs Coalition Letter In Support of the IGNITE American Innovation Act
August 5, 2020
We write as a coalition of advocates for the startup ecosystem to voice our strong support for the IGNITE American Innovation Act, legislation to support startups through the economic crisis by allowing companies to monetize tax assets generated…