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

Bibliographic Details
Corporate Authors:	Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	[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]
Subjects:	Medical instruments and apparatus > Evaluation > Government policy > United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS113041

Description
Item Description:	Title from PDF title page (viewed on May 26, 2009). "Document issued on: June 30, 2008". Electronic resource.
Physical Description:	15 pages : digital, PDF file.
Format:	Mode of access: Internet at the FDA CBER web site. Address as of 5/26/09: http://www.fda.gov/cdrh/mdufma/guidance/1218.pdf ; current access is available via PURL.