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035 a| (OCoLC)1528110392;

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049 a| ERE#;

050 10 a| ISSN RECORD;

074 a| 0475 (online);

082 10 a| 343.085561512| 23/eng/20260113;

086 0 a| HE 20.4002:P 41/3/;

110 1 a| United States.b| Food and Drug Administration,e| author.;

222 0 a| Performance report to Congress for the Biosimilar User Fee Act;

245 10 a| Performance report to Congress for the Biosimilar User Fee Act.;

246 1 a| BsUFA performance report;

246 1 i| Issues for FY 2022- have title:a| Performance report to Congress: Biosimilar User Fee Act;

264 1 a| Silver Spring, Maryland :b| Food and Drug Administration, Department of Health and Human Services,c| 2015-;

300 a| 1 online resource (volumes);

310 a| Annual;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

362 1 a| Began with: FY 2015.;

500 a| Reports include data tables.;

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

500 a| United States federal government branch: Executive branch.;

500 a| Access ID (GovInfo): CMR-HE20_4000-00195421.;

500 a| Legal authority: 21 U.S.C. 379j-53(a).;

500 a| United States Congress receiving chamber(s): United States House of Representatives and Senate.;

500 a| United States Congress receiving committee(s): Committee on Energy and Commerce, Committee on Health, Education, Labor, and Pensions.;

550 a| Prepared in collaboration with: Center for Biologics Evaluation and Research (CBER), 2015-; with: Center for Drug Evaluation and Research (CDER), 2015-;

588 0 a| FY 2015; title from PDF cover (FDA, viewed July 15, 2025).;

588 1 a| FY 2023 (GovInfo, viewed July 15, 2025).;

610 10 a| United States.t| Food and Drug Administration Safety and Innovation Actv| Periodicals.;

610 10 a| United States.b| Food and Drug Administrationx| Rules and practicev| Periodicals.;

610 10 a| United States.b| Food and Drug Administrationx| Financev| Periodicals.;

650 0 a| Biosimilarsz| United Statesx| Testingv| Periodicals.;

650 0 a| Drug approvalz| United Statesx| Costsv| Periodicals.;

650 0 a| Biologicalsx| Law and legislationv| Periodicals.;

650 0 a| User chargesz| United Statesv| Periodicals.;

650 7 a| User charges and fees.2| lst;

710 2 a| Center for Biologics Evaluation and Research (U.S.);

710 2 a| Center for Drug Evaluation and Research (U.S.);

710 1 a| United States.b| Congress.b| House.b| Committee on Energy and Commerce.;

710 1 a| United States.b| Congress.b| Senate.b| Committee on Health, Education, Labor, and Pensions.;

856 40 z| Available at GovInfo3| 2023-u| https://purl.fdlp.gov/GPO/gpo2469017| 0;

856 40 z| Available at FDA3| 2015-u| https://purl.fdlp.gov/GPO/gpo2469097| 0;

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999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6610867-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 8/22/2025x| EDOCUMENTz| JERESOURCEo| .STAFF. jjlm;

Performance report to Congress for the Biosimilar User Fee Act.

Author/creator	United States
Format	Electronic
Publication	Silver Spring, Maryland : Food and Drug Administration, Department of Health and Human Services, 2015-
Description	1 online resource (volumes)
Supplemental Content	Available at GovInfo
Supplemental Content	Available at FDA
Supplemental Content	Address at time of PURL creation
Subjects	United States. Food and Drug Administration Safety and Innovation Act--Periodicals. United States. Food and Drug Administration--Rules and practice. --Periodicals. United States. Food and Drug Administration--Finance. --Periodicals. Biosimilars--United States. --Testing. --Periodicals. Drug approval--United States. --Costs. --Periodicals. Biologicals--Law and legislation. --Periodicals. User charges--United States. --Periodicals.

Other author/creator	Center for Biologics Evaluation and Research (U.S.)
Other author/creator	Center for Drug Evaluation and Research (U.S.)
Other author/creator	United States. Congress. House. Committee on Energy and Commerce.
Other author/creator	United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions.
Variant title	BsUFA performance report
Variant title	Issues for FY 2022- have title: Performance report to Congress: Biosimilar User Fee Act
Frequency	Annual
General note	Reports include data tables.
General note	In scope of the U.S. Government Publishing Office Cataloging and Indexing Program (C&I) and Federal Depository Library Program (FDLP).
General note	United States federal government branch: Executive branch.
General note	Access ID (GovInfo): CMR-HE20_4000-00195421.
General note	Legal authority: 21 U.S.C. 379j-53(a).
General note	United States Congress receiving chamber(s): United States House of Representatives and Senate.
General note	United States Congress receiving committee(s): Committee on Energy and Commerce, Committee on Health, Education, Labor, and Pensions.
Issuing body	Prepared in collaboration with: Center for Biologics Evaluation and Research (CBER), 2015-; with: Center for Drug Evaluation and Research (CDER), 2015-
Source of description	FY 2015; title from PDF cover (FDA, viewed July 15, 2025).
Source of description	FY 2023 (GovInfo, viewed July 15, 2025).
Preceding title	United States. Food and Drug Administration. Performance report to the President and Congress for the Biosimilar User Fee Act 3070-4545
LCCN	2025234771
ISSN	3070-4561
GPO item number	0475 (online)
Govt. docs number	HE 20.4002:P 41/3/

Availability

Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Online Content 2023- 2015- Address at time of PURL creation	✔ Available

Performance report to Congress for the Biosimilar User Fee Act.

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