Performance report to Congress for the Prescription Drug User Fee Act.

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. Prescription Drug User Fee Act of 1992--Periodicals.

United States.

United States. Food and Drug Administration--Finance--Periodicals.

United States. Food and Drug Administration--Rules and practice--Periodicals.

Drugs--United States--Testing--Periodicals.

Drugs.

Drugs--Law and legislation--United States--Periodicals.

Drug approval--United States--Costs--Periodicals.

Drug approval.

Pharmaceutical industry--United States--Periodicals.

Pharmaceutical industry.

User charges--United States--Periodicals.

User charges.

Physical Description:

1 online resource (volumes) : illustrations

Annual

Began with: FY 2014.

Other Title:

PDUFA performance report

Issues for FY 2022- have title: Performance report to Congress: Prescription Drug User Fee Act

Continues:

FY ... performance report to the President and the Congress for the Prescription Drug User Fee Act of 1992 as reauthorized and amended by the Food and Drug Administration Modernization Act of 1997 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Place of Publication:

Silver Spring, Maryland : Food and Drug Administration, Department of Health and Human Services, 2014-

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_4000-00195429.

Legal authority: 21 U.S.C. 379h-2(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), 2014-; with: Center for Drug Evaluation and Research (CDER), 2014-

FY 2014; title from PDF cover (FDA, viewed July 17, 2025).

FY 2023 (GovInfo, viewed July 17, 2025).

OCLC:

1528286138