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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 98D-0693.