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Performance report to Congress for the Biosimilar User Fee Act.

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Format:
Government document
Journal/Periodical
Author/Creator:
United States. Food and Drug Administration, author.
Contributor:
Center for Biologics Evaluation and Research (U.S.)
Center for Drug Evaluation and Research (U.S.)
United States. Congress. House. Committee on Energy and Commerce
United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Language:
English
Subjects (All):
United States. Food and Drug Administration Safety and Innovation Act--Periodicals.
United States.
United States. Food and Drug Administration--Rules and practice--Periodicals.
United States. Food and Drug Administration--Finance--Periodicals.
Biosimilars--United States--Testing--Periodicals.
Biosimilars.
Drug approval--United States--Costs--Periodicals.
Drug approval.
Biologicals--Law and legislation--Periodicals.
Biologicals.
User charges--United States--Periodicals.
User charges.
Physical Description:
1 online resource (volumes)
Annual
Began with: FY 2015.
Other Title:
BsUFA performance report
Issues for FY 2022- have title: Performance report to Congress: Biosimilar User Fee Act
Continues:
United States. Food and Drug Administration. Performance report to the President and Congress for the Biosimilar User Fee Act
Place of Publication:
Silver Spring, Maryland : Food and Drug Administration, Department of Health and Human Services, 2015-
Notes:
Reports include data tables.
In scope of the U.S. Government Publishing Office Cataloging and Indexing Program (C&I) and Federal Depository Library Program (FDLP).
United States federal government branch: Executive branch.
Access ID (GovInfo): CMR-HE20_4000-00195421.
Legal authority: 21 U.S.C. 379j-53(a).
United States Congress receiving chamber(s): United States House of Representatives and Senate.
United States Congress receiving committee(s): Committee on Energy and Commerce, Committee on Health, Education, Labor, and Pensions.
Prepared in collaboration with: Center for Biologics Evaluation and Research (CBER), 2015-; with: Center for Drug Evaluation and Research (CDER), 2015-
FY 2015; title from PDF cover (FDA, viewed July 15, 2025).
FY 2023 (GovInfo, viewed July 15, 2025).
OCLC:
1528110392

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