Guidance for industry M2 : eCTD specification : questions & answers and change requests.
| Other author | Center for Drug Evaluation and Research (U.S.) |
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Other author | International Conference on Harmonisation. |
| Format | Electronic |
| Publication Info | 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] |
| Description | 2 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS114298 |
| Subjects |
| Portion of title | ECTD specification |
| General note | Title from PDF title page (viewed on July 2, 2009). |
| General note | "ICH". |
| General note | "March 2005". |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Technical 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. |
| GPO item number | 0499-T (online) |
| Govt. docs number | HE 20.4702:EL 2 |