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PET Drug Applications - Content and Format for NDAs and ANDAs_2011 August 2011

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

On December 9, 2009, FDA issued a final current good manufacturing practice (CGMP) regulation for the production of positron emission tomography (PET) drugs.2 Under the requirements of section 121 of the Food and Drug Administration Modernization Act (FDAMA), within two years following this publication date, an NDA or ANDA must be submitted for any PET drug marketed for clinical use in the United States. This guidance is intended to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging for the indications cited in Section III (below). FDA approval of an NDA or ANDA will make it possible to market these PET drugs for clinical use according to the requirements of the Federal Food, Drug, and Cosmetic Act (the Act).3

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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