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Guidance Documents/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

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

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

April 23, 1999

July 15, 2024

Center for Biologics Evaluation and Research

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