Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS).
| 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, [2008] |
| Description | ii, 36 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS111878 |
| Subjects |
| Portion of title | Content and review of chemistry, manufacturing, and control (CMC) information for human somatic cell therapy investigational new drug applications (INDS) |
| General note | Title from PDF title page (viewed on Apr. 24, 2009). |
| General note | "April 2008". |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references (p. 27-29). |
| Technical details | Mode of access: Internet at the FDA CBER Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/cmcsomcell.pdf ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:C 42 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |