Drug Safety and Effectiveness : Issues and Action Options After FDA Approval.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Government productivity.

Medical laws and legislation.

Product safety.

Physical Description:

1 online resource (36 pages, digital, PDF file)

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2005.

System Details:

text file

Summary:

Examines issues related to drug safety in the context of the regulatory process that Congress and the FDA have established for ensuring that drugs are safe and effective. Describes FDA process for approving new drugs, and examines FDA and industry role in postmarket regulation of approved drugs. Discusses problems in identifying and resolving postmarketing safety and effectiveness issues, and outlines FDA and Congressional options for improving postmarket activities.

Notes:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Dec. 2010). Reuse except for individual research requires license from ProQuest, LLC.

CRS Report.

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. Drug Safety and Effectiveness

Access Restriction:

Restricted for use by site license.