Guidance for FDA reviews and sponsors : : content and review of chemistry, manufacturing, and control (CMC) information for human gene 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 | 1 online resource (ii, 34 p.) |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS111884 |
| Subjects |
| Portion of title | Content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (INDs) |
| General note | Title from title screen (viewed on Apr. 24, 2009). |
| General note | "April 2008". |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references (p. 32-34). |
| Technical details | Mode of access: Internet at the GPO Web site. Address as of 4/24/09: http://www.fda.gov/cber/gdlns/gtindcmc.pdf ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:C 42/2 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |