Regulatory Roundup: FDA Addresses the Regulation and Approval Process of PET Drugs

FDA issued last week a series of questions and answers regarding the regulation and approval process of positron emission tomography (PET) drugs. The agency published regulations on cGMP standards for PET drug manufacturers in late 2009. The Q&A guidance aims to respond to follow-up questions from the industry. Addressed are application extensions, inspections, CTD filings, the use of synthesizers, IND sponsors, trials, and more.