Research Catalog

Title

Guidance for industry [electronic resource] : granularity document : annex to M4, organization of the CTD.

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, [2005]

Details

Additional Authors

• Center for Biologics Evaluation and Research (U.S.)
• International Conference on Harmonisation.

Description

10 p. : digital, PDF file.

Alternative Title

• Granularity document
• Annex to M4, organization of the CTD

Subject

• Center for Drug Evaluation and Research (U.S.)
• Clinical trials > Reporting

Note

• Title from PDF title page (viewed on June 22, 2009).
• "ICH".
• "October 2005".

System Details (note)

• Mode of access: Internet at theFDA web site. Address as of 6/22/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129576.pdf ; current access is available via PURL.

Call Number

GPO Internet HE 20.4702:G 76

OCLC

405716933

Title

Guidance for industry [electronic resource] : granularity document : annex to M4, organization of the CTD.

Imprint

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, [2005]

System Details

Mode of access: Internet at theFDA web site. Address as of 6/22/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129576.pdf ; current access is available via PURL.

Connect to:

http://purl.access.gpo.gov/GPO/LPS113972

Added Author

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

International Conference on Harmonisation.

Gpo Item No.

0499-T (online)

Sudoc No.

HE 20.4702:G 76

Research Call Number

GPO Internet HE 20.4702:G 76