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
Ag Biotech Alliance Response to Biotech RFI
ABA has submitted comments to the Office of Science & Technology Policy on how regulations underpinning the Coordinated Framework for the Regulation of Biotechnology can better facilitate the use of biotechnology to stimulate the economy…
BIO Response to Biotech RFI
BIO has submitted comments to the Office of Science & Technology Policy on how regulations underpinning the Coordinated Framework for the Regulation of Biotechnology can better facilitate the use of biotechnology to stimulate the economy…
BIO comments to USTR on the Agency’s 2023 Special…
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November 14, 2022
BIO submitted a statement for the record to the Senate Committee on Agriculture, Nutrition and Forestry hearing titled "Farm Bill 2023: Rural Development and Energy Programs." BIO called for a "farm bill centered on innovation" to incentivize…
November 1, 2022
On November 1st, BIO submitted comments in response to the Food & Drug Administration’s (FDA) recent Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. The meeting was primarily focused on two topics: the future of the…
October 28, 2022
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on…
October 28, 2022
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how…
October 11, 2022
Nearly 400 companies and trade associations wrote House and Senate leaders about the need to reverse a harmful tax change--a new requirement to amortize R&D expenses--that threatens jobs and innovation.
September 29, 2022
BIO and 24 other organizations call on the Biden Administration to discuss supply chains and food security in future High-Level Economic Dialogue meetings.
September 28, 2022
On Wednesday, September 28th, BIO submitted comments to the Food & Drug Administration on the ICH Q2(R2) Guideline: Validation of Analytical Procedures and the ICH Q14 Guideline: Analytical Procedure Development. In addition to a number of…
September 26, 2022
On Monday, September 26th, BIO submitted comments in response to the FDA’s draft guidance on clinical pharmacology considerations for development of oligonucleotide therapeutics, which provided recommendations on when certain PKPD assessments may be…
September 26, 2022
We are writing to express our strong opposition to any form of expansion of the WTO TRIPS waiver to COVID-19 therapeutics or diagnostics. Support for an intellectual property (IP) waiver would send U.S.-developed innovative technologies and…