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GUIDANCE DOCUMENT

Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices December 2011

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2011-D-0868
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Veterinary Medicine

                                            


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: FDA-2011-D-0868.

 
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