FDA Releases New Draft Guidance on Positron Emission Tomography Products
The US Food and Drug Administration (FDA) released new draft guidance for industry on 3 February that covers the regulation of positron emission tomography (PET) drugs. The guidance is intended to address numerous aspects of the drug regulatory process, including the submission and review of an application, regulatory compliance, inspections, registration and listing and associated user fees.
Guidance: FDA Regulation of PET Drug Products - Questions and Answers should be useful to any sponsor of a drug product submission either a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA). NDAs are typically used to submit drugs with novel mechanisms of action, while ANDAs are typically generic products that reference an already-approved product.
The document covers a comprehensive list of 98 questions and answers that cover "nearly all aspects of the drug regulatory process," according to FDA.
Comments on the proposed guidance are due within 90 days of the date of publication.