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

Article

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.

Recent Videos
Industry Outlook 2025: The Rising Prominence of AI in Pharma
Leroy Hood, MD, PhD