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FDA user fee reauthorization : ensuring safe and effective drugs and biologics : hybrid hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Seventeenth Congress, second session, February 3, 2022.
Connect to full text Available online
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- Book
- Government document
- Author/Creator:
- United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health, author.
- Language:
- English
- Subjects (All):
- United States. Food and Drug Administration.
- United States.
- Medical supplies--Law and legislation--United States.
- Medical supplies.
- Drug reimportation--United States.
- Drug reimportation.
- Prescription pricing--United States.
- Prescription pricing.
- Drugs--Safety measures--Government policy--United States.
- Drugs.
- Consumer protection--United States.
- Consumer protection.
- User charges--United States.
- User charges.
- Genre:
- Legislative hearings.
- Physical Description:
- 1 online resource (vi, 223 pages) : color illistrations
- Other Title:
- Food and Drug Administration user fee reauthorization
- Ensuring safe and effective drugs and biologics
- Place of Publication:
- Washington : U.S. Government Publishing Office, 2026.
- Participant:
- Hearing witnesses: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration\1\ Prepared statement; Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration\1\ Prepared statement; Lucy Vereshchagin, Ph.D., Vice President, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America; Cartier Esham, Ph.D., Chief Scientific Officer, Executive Vice President, Emerging Companies, Biotechnology Innovation Organization; Juliana M. Reed, President, Biosimilars Forum; David Gaugh, Senior Vice President, Science and Regulatory Affairs, Association for Accessible Medicines; Reshma Ramachandran, M.D., Chair, Doctors for America FDA Task Force, Physician-Fellow, Yale National Clinician Scholars Program,; H.R. the Biosimilar User Fee Amendments of 2022 \2\ H.R. the Generic Drug User Fee Amendments of 2022 \2\ H.R. the Prescription Drug User Fee Amendments of 2022 \2\ Article "Accelerated Approval is not Conditional Approval: Insights From International Expedited Approval Programs", JAMA, Viewpoint, submitted by Ms. Eshoo.
- Notes:
- This is a publication issued by the United States federal government or produced with federal funds.
- Associated bill citation(s): H.R. 1730; H.R. 5416; H.R. 6000.
- "Serial no. 117-65."
- Includes bibliographical references.
- Date of hearing: 2022-02-03.
- Description based on online resource, PDF version; title from title page (GovInfo, viewed Mar. 11, 2026).
- In scope of the U.S. Government Publishing Office Cataloging and Indexing Program (C&I) and Federal Depository Library Program (FDLP).
- Other Format:
- Print version: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health. FDA user fee reauthorization
- OCLC:
- 1578873158
- Publisher Number:
- 57-563 (GPO jacket number)
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