Guidance for industry on the content and format of chemistry, manufacturing and controls information and establishment description information for an allergenic extract or allergen patch test.
| 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, [1999] |
| Description | iii, 23 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS113493 |
| Subjects |
| Portion of title | Content and format of chemistry, manufacturing and controls information and establishment description information for an allergenic extract or allergen patch test |
| General note | Title from PDF title page (viewed on June 4, 2009). |
| General note | "April 1999". |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Technical details | Mode of access: Internet at the FDA web site. Address as of 6/4/09: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Allergenics/ucm078638.pdf ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:C 76/3 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |