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GUIDANCE DOCUMENT

Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs December 2012

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2012-D-0081
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug. This guidance does not describe all the considerations relevant to an Expanded Access submission or to an IND Request to Charge submission. For details about these processes, we encourage sponsors to review the applicable regulations and advice available on the FDA Web site, and consult the review division, if necessary.

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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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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0081.

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