Proposed FDA User Fee Acts : Generic Drug User Fee Amendments of 2012 (GDUFA) and Biosimilar User Fee Act of 2012 (BSUFA).

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Contributor:

Library of Congress. Congressional Research Service. Resources, Science, and Industry Division.

Language:

English

Subjects (All):

Drugs.

Medical economics.

Medical laws and legislation.

User charges.

Physical Description:

1 online resource (1 online resource (27 p), digital, PDF file)

monochrome

Place of Publication:

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

System Details:

text file

Summary:

Profiles generic drugs and biosimilar products. Summarizes the Generic Drug User Fee Amendments of 2012 and the Biosimilar User Fee Act of 2012, to supplement funding appropriated by Congress to FDA for activities related to human generic drug review and biosimilar biological product review respectively, and to reauthorize prescription drug and medical device user fee authorities.

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. Proposed FDA User Fee Acts

Access Restriction:

Restricted for use by site license.