FDA User Fees and the Regulation of Drugs, Biologics, and Devices : Comparative Analysis of S. 3187 and H.R. 5651.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Pediatrics.

Medical economics.

Medical laws and legislation.

Medical supplies.

Physical Description:

1 online resource (1 online resource (100 p), digital, PDF file)

monochrome

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2012.

System Details:

text file

Summary:

Provides side-by-side comparison of S. 3187, the Food and Drug Administration Safety and Innovation Act, and H.R. 5651, the Food and Drug Administration Reform Act of 2012, both to reauthorize FDA authority to collect user fees and to amend the Federal Food, Drug, and Cosmetic Act and other acts to extend and revise FDA regulation of human drugs, biological products, and medical devices. Analyzes major provisions of these bills related to user fee acts, pediatric medical products, human medical device regulation, human drug regulation, advisory committees, and administrative reforms and miscellaneous topics.

Notes:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Apr. 2014). Reuse except for individual research requires license from ProQuest, LLC.

CRS Report.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. FDA User Fees and the Regulation of Drugs, Biologics, and Devices

Access Restriction:

Restricted for use by site license.