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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
John F. Crowley, President and CEO of the…
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
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CSBA Letter to Congressional Leadership on Most…
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CSBA Letter to Congressional Leadership on…
The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory-based non-profit trade associations, each of which advocates for public policies that support responsible development and delivery of innovative…
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Geno Testimony to Senate Agriculture Committee on Farm Bill
November 15, 2022
BIO Statement to Senate Ag Committee Hearing on Farm Bill Rural Development & Energy Programs
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…
BIO Submits Comments on Quality Management Maturity (QMM) Program and Knowledge-Aided Assessment and Structured Application (KASA)
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…
BIO Submits Comments on WHO Guideline: Nonclinical and Clinical Evaluation of Monoclonal Antibodies and Related Biological Products Intended for the Prevention or Treatment of Human Infectious Diseases
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…
BIO Submits Comments on ICH Guideline: E11A Pediatric Extrapolation
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…
Letter to Congress Re Tax Treatment of R&D Expenses
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.
Coalition Letter to Pres. Biden on High-Level Economic Dialogue with Mexico
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.
BIO Comments on ICH Guidelines: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
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…
BIO Submits Comments on FDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
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…
BIO Sends Letter to President Biden Strongly Opposing Expansion of the WTO TRIPS Waiver
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…