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GUIDANCE DOCUMENT

Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products August 1999

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1998-D-0003
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance document provides guidance on general principles for the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.

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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: FDA-1998-D-0003.

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