Research Catalog

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

Title
Guidance for industry : M2, 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

https://purl.fdlp.gov/GPO/LPS117360

Details

Additional Authors
  • Center for Drug Evaluation and Research (U.S.)
  • Center for Biologics Evaluation and Research (U.S.)
  • International Conference on Harmonisation.
Description
1 online resource (2 pages)
Alternative Title
M2, eCTD specification, questions & answers and change requests
Subject
  • Document imaging systems > United States
  • Drug approval > United States
Note
  • "ICH."
  • "March 2005."
Call Number
GPO Internet HE 20.4702:EL 2/6
OCLC
marcive475038649
Title
Guidance for industry : M2, eCTD specification, questions & answers and change requests.
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, [2005]
Type of Content
text
Type of Medium
computer
Type of Carrier
online resource
Connect to:
https://purl.fdlp.gov/GPO/LPS117360
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 2/6
View in Legacy Catalog