Letters, Testimony & Comments

Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access…

The undersigned food and agriculture trade associations respectfully urge confirmation of Katherine Tai to be U.S. Trade Representative. Our associations represent the vast majority of the food and agriculture sector accounting for roughly one…

On behalf of the Biotechnology Innovation Organization (BIO), the nearly 1000 companies, universities, and biotech organizations we represent comprised of millions of scientists, researchers and entrepreneurs, congratulations on your historic…

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On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins.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October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.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…