GUIDANCE DOCUMENT
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices December 2011
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2011-D-0868
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Veterinary Medicine
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All written comments should be identified with this document's docket number: FDA-2011-D-0868.