Guidance for Industry on the Content and Format of Chemistry, Manufacturing and211 Controls Information and Establishment Description Information for an Allergenic 211 Extract or Allergen Patch Test

摘要

This document provides guidance on the content and format of the Chemistry,211u001eManufacturing, and Controls (CMC) section of a Biologics License Application for 211u001ean Allergenic Extract or Allergen Patch Test.