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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| 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 |
| Internet: | http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Allergenics/ucm078638.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ |
| Content: | This document provides guidance on the content and format of the Chemistry, Manufacturing, and Controls (CMC) section of a Biologics License Application for an Allergenic Extract or Allergen Patch Test. |
| Document Type: | Guidance for Industry |
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