FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals
Contributors: Center for Biologics Evaluation and Research (U.S.)
Publisher: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health; Center for Biologics Evaluation and Research
Published: 2008
Place of publication: Rockville, MD]
Language: eng
Format: [electronic resource]
Number of pages: 15
Subjects: Medical instruments and apparatus; Evaluation; Government policy
Other titles: Guidance for industry and FDA staff
Notes: Title from PDF title page (viewed on May 26, 2009).

"Document issued on: June 30, 2008".

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.