Guidance for industry : CGMP for phase 1 investigational drugs.
| Other author | Center for Drug Evaluation and Research (U.S.) |
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Other author | United States. Food and Drug Administration. Office of Regulatory Affairs. |
| 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 : Office of Regulatory Affairs, [2008] |
| Description | 17 pages : digital, PDF file. |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS111655 |
| Subjects |
| Portion of title | CGMP for phase 1 investigational drugs |
| General note | Title from PDF title page (viewed on Apr. 21, 2009). |
| General note | "July 2008." |
| Bibliography note | Includes bibliographical references (p. 17). |
| Technical details | Mode of access: Internet at the FDA CBER Web site. Address as of 4/21/09: http://www.fda.gov/cber/gdlns/indcgmp.pdf ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:IN 8 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |