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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
BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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BIO Letter to the EEOC on Special Carve Outs
December 5, 2022
Notice of Availability and Request for Comment: Equal Employment Opportunity Commission (EEOC) Draft Strategic Plan 2022–2026
Coalition Letter in Support of McKalip & Taylor Nominations
November 29, 2022
A coalition of groups, including BIO and several of its member companies, wrote Senate leaders urging confirmation of Doug McKalip as Chief Agricultural Negotiator for USTR and Alexis Taylor as Under Secretary for Trade and Foreign Agricultural…
Letter from BIO, along with 150+ health-focused organizations, to congressional leaders urging passage of the PASTEUR Act
November 16, 2022
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.