UPDATE: FDA has posted new draft guidance – FDA Oversight of PET Drug Products, Questions and Answers.
FDA has published a revised version of the FAQ guidance initially published on the agency’s website on February 2, 2012. The guidance is intended to help producers of 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 CGMPs, inspections, registration and listing and user fees.
The guidance is available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Comments and suggestions regarding this draft document should be submitted either electronically or written documents by May 29, 2012.