Research Catalog

Title

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

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]

Details

Additional Authors

• Center for Devices and Radiological Health (U.S.)
• Center for Biologics Evaluation and Research (U.S.)

Description

15 pages : digital, PDF file

Alternative Title

Guidance for industry and FDA staff

Subject

Medical instruments and apparatus > United States > Evaluation > Government policy

Note

• Title from PDF title page (viewed on May 26, 2009).
• "Document issued on: June 30, 2008".

System Details (note)

• 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.

Call Number

GPO Internet HE 20.4802:P 91/3

OCLC

marcive351377973

Title

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

Publisher

[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]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

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.

Connect to:

https://purl.fdlp.gov/GPO/LPS113041

Added Author

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

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

Gpo Item No.

0499-T-02 (online)

Sudoc No.

HE 20.4802:P 91/3