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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
In the Federal Register of July 8, 1997 (62 FR 36558), the Food and Drug Administration (FDA) announced the availability of the revised Form FDA 356h, Biologics License Application (BLA) entitled 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 and the Establishment
Description section of a Biologics License Application for a Human Plasma-Derived Biological Product, Animal Plasma or Serum-Derived Product. For these products, FDA is now implementing the BLA (revised Form FDA 356h) and will accept that application, instead of two separate license application submissions, the product license application (PLA) and the establishment license application (ELA).
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-0007.