Research Catalog

Guidance for industry M2 eCTD specification : questions & answers and change requests.

Title
Guidance for industry M2 [electronic resource] : eCTD specification : questions & answers and change requests.
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]

Available Online

http://purl.access.gpo.gov/GPO/LPS114298

Details

Additional Authors
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Biologics Evaluation and Research (U.S.)
  • International Conference on Harmonisation.
Description
2 p. : digital, PDF file.
Alternative Title
ECTD specification
Subject
Document imaging systems > Government policy > United States
Note
  • Title from PDF title page (viewed on July 2, 2009).
  • "ICH".
  • "March 2005".
System Details (note)
  • Mode of access: Internet at the FDA web site. Address as of 7/2/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129614.pdf ; current access is available via PURL.
Call Number
GPO Internet HE 20.4702:EL 2
OCLC
421114478
Title
Guidance for industry M2 [electronic resource] : eCTD specification : questions & answers and change requests.
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 the FDA web site. Address as of 7/2/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129614.pdf ; current access is available via PURL.
Connect to:
http://purl.access.gpo.gov/GPO/LPS114298
Added Author
Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
International Conference on Harmonisation.
Gpo Item No.
0499-T (online)
Sudoc No.
HE 20.4702:EL 2
Research Call Number
GPO Internet HE 20.4702:EL 2
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