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

Docket Number:: FDA-1996-D-0071
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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All written comments should be identified with this document's docket number: FDA-1996-D-0071.

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

Submit Comments

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