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GUIDANCE DOCUMENT

Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use August 1996

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
96D-0344
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

In the Federal Register of May 14, 1996, the Food and Drug Administration published the final rule ?Elimination of the Establishment License Application for Specified Biotechnology and Specified Synthetic Biological Products”. Under this rule manufacturers of therapeutic recombinant DNA-derived products and/or monoclonal antibody products for in vivo use are no longer required to submit an Establishment License Application and may use the interim FDA Form 3439.

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Submit Comments Online

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: 96D-0344.

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