Guidance for industry : submitting type V drug master files to the Center for Biologics Evaluation and Research.
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Format | Electronic |
| Publication Info | Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2001] |
| Description | i, 5 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS113193 |
| Subjects |
| Portion of title | Submitting type V drug master files to the Center for Biologics Evaluation and Research |
| General note | Title from PDF title page (viewed on May 28, 2009). |
| General note | "Draft guidance". |
| General note | "August 2001". |
| General note | Includes bibliographical references (p. 5). |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Technical details | Mode of access: Internet at the FDA CBER web site. Address as of 5/28/09: http://www.fda.gov/cber/gdlns/dmfv.pdf ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:D 84/2 |