FDA releases guidance for content and format for NDAs and ANDAs of PET applications

The U.S. Food and Drug Administration has released a new draft guidance "PET Drug Applications — Content and Format for NDAs and ANDAs" intended to assist applicants in preparing new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for certain drugs used in PET (Positron Emission Tomography) imaging.

The content and format sections of the draft guidance provide information required to submit an NDA or an ANDA for these PET drugs. An application may be submitted in paper or electronically with electronic submissions being the preferred option. In this case, the electronic submission should follow the eCTD format.

[Source: FDA website]

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