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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's response to HHS Request for Information:…
Below is BIO's formal response to the Department of Health and Human Services' (HHS) request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making 
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HHS TrialBlazer: BIO Comment Letter – FDA 2019-D…
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HHS TrialBlazer: PhRMA-BIO Comment Letter – OIG…
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BIO Comments on FDA Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs
December 13, 2022
On Tuesday, December 13th, BIO submitted comments in response to a recent FDA discussion paper for stakeholders on distributed manufacturing (DM) and point-of-care (POC) manufacturing. In the comments submitted, BIO commended the FDA on its…
BIO/Stakeholder letter to the Senate Judiciary Committee in opposition to the “Pride in Patent Ownership Act” (S. 2774)
December 9, 2022
Letter to the U.S. Patent and Trademark Office offering recommendations to strengthen the Patent Trial and Appeal Board (PTAB) process
December 9, 2022
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…