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024 8 a| 57-563q| (GPO jacket number);

035 a| (Sirsi) o1578873158;

035 a| (OCoLC)1578873158;

042 a| pcc;

043 a| n-us---;

049 a| ERE#;

074 a| 1019-C-01 (online);

086 0 a| Y 4.C 73/8:117-65;

088 a| Serial no. 117-65 (United States. Congress. House. Committee on Energy and Commerce);

245 10 a| FDA user fee reauthorization :b| 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.;

246 3 a| Food and Drug Administration user fee reauthorization;

246 30 a| Ensuring safe and effective drugs and biologics;

264 1 a| Washington :b| U.S. Government Publishing Office,c| 2026.;

300 a| 1 online resource (vi, 223 pages) :b| color illistrations;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

500 a| This is a publication issued by the United States federal government or produced with federal funds.;

500 a| Associated bill citation(s): H.R. 1730; H.R. 5416; H.R. 6000.;

500 a| "Serial no. 117-65.";

504 a| Includes bibliographical references.;

511 0 a| 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.;

518 a| Date of hearing: 2022-02-03.;

588 a| Description based on online resource, PDF version; title from title page (GovInfo, viewed Mar. 11, 2026).;

500 a| In scope of the U.S. Government Publishing Office Cataloging and Indexing Program (C&I) and Federal Depository Library Program (FDLP).;

610 10 a| United States.b| Food and Drug Administration.=| ^A1253;

650 0 a| Medical suppliesx| Law and legislationz| United States.=| ^A450443;

650 0 a| Drug reimportationz| United States.=| ^A868939;

650 0 a| Prescription pricingz| United States.=| ^A5242;

650 0 a| Consumer protectionz| United States.=| ^A25301;

650 0 a| User chargesz| United States.=| ^A420592;

650 7 a| Health.2| cgpa;

650 7 a| Commerce.2| cgpa;

655 7 a| Legislative hearings.2| lcgft;

776 08 i| Print version:a| United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health.t| FDA user fee reauthorizationw| (OCoLC)1578872728;

856 40 u| https://purl.fdlp.gov/GPO/gpo2538217| 0;

856 4 z| Address at time of PURL creationu| https://www.govinfo.gov/content/pkg/CHRG-117hhrg57563/pdf/CHRG-117hhrg57563.pdf;

949 a| Click on web addressw| asish| joyner94o| jjlm;

994 a| C0b| GPO;

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999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6722848-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 4/28/2026x| EDOCUMENTz| JERESOURCEo| .STAFF. jjlm;

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.

Author/creator	United States
Format	Electronic
Publication	Washington : U.S. Government Publishing Office, 2026.
Description	1 online resource (vi, 223 pages) : color illistrations
Supplemental Content	https://purl.fdlp.gov/GPO/gpo253821
Supplemental Content	Address at time of PURL creation
Subjects	United States. Food and Drug Administration. Medical supplies--Law and legislation. --United States. Drug reimportation--United States. Prescription pricing--United States. Drugs--Safety measures. --Government policy. --United States. Consumer protection--United States. User charges--United States.

Variant title	Food and Drug Administration user fee reauthorization
Portion of title	Ensuring safe and effective drugs and biologics
General note	This is a publication issued by the United States federal government or produced with federal funds.
General note	Associated bill citation(s): H.R. 1730; H.R. 5416; H.R. 6000.
General note	"Serial no. 117-65."
General note	In scope of the U.S. Government Publishing Office Cataloging and Indexing Program (C&I) and Federal Depository Library Program (FDLP).
Bibliography note	Includes bibliographical references.
Performer	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.
Date/time/place of a event note	Date of hearing: 2022-02-03.
Source of description	Description based on online resource, PDF version; title from title page (GovInfo, viewed Mar. 11, 2026).
Issued in other form	Print version: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health. FDA user fee reauthorization
Genre/form	Legislative hearings.
Standard identifier#	57-563 (GPO jacket number)
Technical rpt number	Serial no. 117-65 (United States. Congress. House. Committee on Energy and Commerce)
GPO item number	1019-C-01 (online)
Govt. docs number	Y 4.C 73/8:117-65

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Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Online Content https://purl.fdlp.gov/GPO/gpo253821 Address at time of PURL creation	✔ Available

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.

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