This post was also written by Erin A. Janssen.
The FDA released draft guidance on February 2, 2012 entitled “FDA Regulation of PET Drug Products – Questions and Answers.” The guidance is intended to help producers of positron emission tomography (PET) drugs meet the requirements for FDA’s drug approval process. The guidance provides approximately 100 questions and answers that address nearly all aspects of the drug regulatory process, including application submission, review, compliance with current good manufacturing practices, inspections, registration and listing, and user fees. The first answer reminds producers of PET drugs that FDA does not intend to disrupt existing clinical use of PET drugs as long as “appropriate submissions are made and producers of PET drugs are moving to comply with regulatory requirements.” For the next 6 months, until June 12, 2012, FDA does not intend to take enforcement action against a PET facility currently producing PET drugs for clinical use for a failure to submit an NDA by December 12, 2011, provided that the facility complies with all other FDA requirements, including current good manufacturing practices (CGMPs). FDA will not exercise enforcement discretion after June 12, 2012.