Home
Search

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…
Learn more
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…
Learn more
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…
Learn more
All Letters, Testimony & Comments
  • Show All
Search
Results
BIO's 2021 Special 301 Submission
January 28, 2021
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…
BIO Joins Letter Supporting Katherine Tai to Lead USTR
January 26, 2021
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…
BIO Letter to Biden Administration on Climate Crisis
January 25, 2021
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…
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…