BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.
Featured Letters, Testimony, & Comments
BIO Comments on FDA’s Public Workshop on…
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…
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…
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…
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…
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…
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…
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins.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…
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…
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Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.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…
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…
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…
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…
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…
