- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h "Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use"
In the Federal Register of July 8, 1997 (62 FR 36558), the Food and Drug Administration (FDA) announced the availability of Revised Form FDA 356h, “Application to Market a New Drug, Biologic, or an Antibiotic for Human Use.”3, 5 This document provides guidance on the completion of this form and the content and format of the Chemistry, Manufacturing, and Controls (CMC) section and the Establishment Description section of a License Application for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture. For these products, FDA is now implementing the BLA (revised Form FDA 356h) and will accept biologics license applications 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-0512.