SNMMI continues to be an active participant in the Coalition for PET Drugs. The Coalition's purpose is to help the PET community understand requirements related to the implementation of 21 CFR part 212 and the submission process for PET NDAs or ANDAs, and to make a positive impact on the overall implementation process through interaction with the FDA.
On June 17, 2020, the Coalition for PET Drugs participated in an FDA Townhall hosted by SNMMI on the Impact of COVID-19 on submission mechanisms, facility inspections, and general regulatory changes. You may find the webinar slide deck here, FDA's responses to questions un-answered during the townhall here, and the webinar video file here.
On Friday, February 21, 2020, SNMMI, alongside the Food and Drug Administration (FDA), Coalition for PET Drugs, Medical Imaging Technology Alliance (MITA), and World Molecular Imaging Society (WMIS) hosted a workshop entitled “PET Drugs: A Workshop on Inspections Management and Regulatory Issues.” The purpose of this workshop was to provide a forum for the exchange of information and perspectives on the regulatory and compliance framework for PET drug manufacturing. You can find both slides and the webinars here.
Please visit the Coalition website for the most up-to-date information on Part 212: www.CoalitionforPETDrugs.org