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GUIDANCE DOCUMENT

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 Guidance for Industry May 1999

Final

This guidance is being distributed for comment purposes only.

Docket Number:
98D-0512
Issued by:
Guidance Issuing Office
Center 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).


Submit Comments

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:

Dockets Management
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.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010