Research Catalog

Title

Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports.

Publication

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

Details

Additional Authors

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

Description

8 pages : digital, PDF file

Alternative Title

Providing regulatory submissions in electronic format, postmarketing indivudal case safety reports

Subject

• Drug testing > United States > Case studies
• Electronic filing systems > United States

Note

• Title from PDF title page (viewed on Apr. 23, 2009).
• "Draft guidance".
• "June 2008."

System Details (note)

• Mode of access: Internet at the FDA CBER Web site. Address as of 4/23/09: http://www.fda.gov/cber/gdlns/postelect.pdf ; current access is available via PURL.

Call Number

GPO Internet HE 20.4802:R 26/2

OCLC

marcive319065082

Title

Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports.

Publisher

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : 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 4/23/09: http://www.fda.gov/cber/gdlns/postelect.pdf ; current access is available via PURL.

Connect to:

https://purl.fdlp.gov/GPO/LPS111793

Added Author

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

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

Gpo Item No.

0499-T-02 (online)

Sudoc No.

HE 20.4802:R 26/2