GUIDANCE DOCUMENT
Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry December 2017
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2017-D-6554
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
Guidance for Industry
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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All written comments should be identified with this document's docket number: FDA-2017-D-6554.