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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter 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.
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: 96D-0344.