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FDA 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


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
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.

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