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GUIDANCE DOCUMENT

FDA Oversight of PET Drug Products -- Questions and Answers December 2012

Final Level 1 Guidance

FDA Oversight of PET Drug Products -- Questions and Answers

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to help producers of positron emission tomography (PET) drugs meet the requirements for FDA’s drug approval process. This guidance provides questions and answers that address nearly all aspects of the drug regulatory process, including application submission, review, compliance with current good manufacturing practices, inspections, registration and listing, and user fees.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.