Competitive Problems in the Drug Industry : Drug Testing.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Administrative law.

Bibliography.

Drugs.

Physical Description:

1 online resource (147 pages) : digital, PDF file

monochrome

Place of Publication:

[Place of publication not identified] : [publisher not identified], 1979-1980.

System Details:

System requirements: PDF reader software.

text file

PDF

Summary:

Appendices (pages 115-142) include bibliography (pages 115-118) and "General Considerations for the Clinical Evaluation of Drugs," FDA, Sept. 1977 (pages 129-142).

Report, prepared by Janet E. Lemke (CRS) in anticipation of 96th Congress consideration of S. 1075, the Drug Regulation Reform Act of 1979, reviewing problems with the FDA system of drug testing and evaluation raised during 1968-69 hearings before the Subcom on Monopoly. Contains update of drug testing issues, including difficulty in selecting an independent investigator to conduct drug tests, substandard quality of drug tests, use of humans in drug tests, and delays in FDA approval of new drugs.

Notes:

CRS Report.

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

Other Format:

Microfiche version: Library of Congress. Congressional Research Service. Competitive Problems in the Drug Industry:. 79-S722-15

Access Restriction:

Restricted for use by site license.