FDA Publish Guidance on PET Drug Applications

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On December 9, 2009, FDA issued a final current good manufacturing practice (CGMP) regulation for the production of positron emission tomography (PET) drugs. 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).
The guidance (1) provides brief background information, (2) makes recommendations to help you decide whether you should submit an NDA or an ANDA, (3) includes a description of the content and format needed in an NDA and an ANDA, and (4) provides boxed text that you can copy or cut and paste into your application. The content and format sections provide information required to submit an NDA or an ANDA for these PET drugs. Finally, we have developed sample formats for the chemistry sections and for the proposed labeling for fludeoxyglucose F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection as well as 356h sample forms. These formats are supplied as separate documents on FDA’s web site.
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 apply. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Because this guidance discusses in great detail what must be submitted in an NDA (particularly a 505(b)(2) NDA) or an ANDA (505(j)), the guidance differs from most guidances in that it contains extensive mandatory language, especially in the Appendices. This mandatory language is used whenever the Act and/or FDA regulations require the submission of certain information. Unlike other documents in which mandatory language is accompanied by the related cite, to make the guidance more user friendly and less cumbersome, we do not cite each regulation each time we discuss a requirement.

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