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GUIDANCE DOCUMENT

On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test Guidance for Industry April 1999

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
98D-0693
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

In the Federal Register of July 8, 1997, the Food and Drug Administration announced the availability of Revised Form FDA 356h “Application to Market a New Drug, Biologic, or an Antibiotic for Human Use.” 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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All written comments should be identified with this document's docket number: 98D-0693.

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