Guidance Details Requirements for PET Drug NDAs, ANDAs

The FDA has issued a draft guidance on the required content and format of NDAs and ANDAs for drugs used in positron emission tomography (PET) scans. The agency is issuing the guidance because “many PET drug producers are unfamiliar with the drug approval process,” according to a notice in the Federal Register. Makers of PET drugs were not required to submit NDAs and ANDAs before the FDA Modernization Act of 1997 set new requirements for the products. Applications from manufacturers of PET drugs for clinical use are due by Dec. 12.
Washington Drug Letter