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Changes to an Approved Application: Biological Products Guidance for Industry July 1997

Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

Frequently, a licensed applicant determines that it is appropriate to make a change in the product, labeling, production process, quality controls, equipment, facilities, or responsible personnel established in the approved license application(s). Section 601.12 of Title 21 of the Code of Federal Regulations (21 CFR 601.12) prescribes the requirements for reporting such changes for licensed biological products to FDA.

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: 95D-0052.


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