February 6, 2012
On February 2, 2012, the Food and Drug Administration (FDA) issued draft FAQ guidance for PET drugs entitled, “FDA Regulation of PET Drug Products, Questions and Answers.” 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/Guidances/UCM290024.pdf.
A 90 day comment period will begin once the notice is published in the Federal Register.