FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals.

Format:

Book

Government document

Contributor:

Center for Devices and Radiological Health (U.S.)

Center for Biologics Evaluation and Research (U.S.)

Language:

English

Subjects (All):

Medical instruments and apparatus--Evaluation--Government policy--United States.

Medical instruments and apparatus.

United States.

Physical Description:

1 online resource (15 pages)

Other Title:

At head of title: Guidance for industry and FDA staff

Place of Publication:

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008]

Notes:

Title from PDF title page (viewed on May 26, 2009).

"Document issued on: June 30, 2008."

OCLC:

351377973