The Coalition for PET Drug Approval recently sponsored a session focused on FDA topics for PET drug manufacturers. The session was held at the 2014 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in St. Louis. The session drew more than 100 attendees, representing academic PET drug manufacturers, commercial PET drug manufacturers, FDA representatives, and others. Five speakers covered a range of topics including Coalition activities, ANDA/NDA submission considerations, how to handle FDA inspections, and post-approval commitments for NDA and ANDA holders. The presentations generated numerous questions from the audience, including discussions of next steps and potential sessions at next year’s annual meeting of the SNMMI.
In case you missed the session, the presentations are available here:
- 1 Vanbrocklin_Coalition PET Drug Approval Update_9June2014
- 2 Schwarz_Coalition Survey Results_9June2014
- 3 Wolfangel_Acceptable Review Commitments_9June2014
- 4 Ehrhardt_Acceptable Practices GMP_9Jun2014
- 5 Nazerias_Post Approval Commitments_9June2014
We hope the session was helpful for the PET community and we welcome your feedback. If you have any comments or questions related to the presentations or the sessions, please contact the Coalition at the link above or leave a comment below.