As we have done in past years, the Coalition for PET Drug Approval recently sponsored a session focused on FDA topics for PET drug manufacturers. The session was held at the 2015 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in Baltimore. For the first time, the session was co-sponsored with the Radiopharmaceutical Sciences Council (RPSC) of the SNMMI. This is an important development as it demonstrates the alignment of the Coalition’s mission with that of the RPSC. Although the two groups have seemingly divergent missions, they share the goal of supporting a science-based approach to regulatory issues. This is a very exciting collaboration!
The session also included an additional ad hoc meeting to discuss recent developments at the US Pharmacopeia that are pertinent to PET drug manufacturers and nuclear medicine in general. The session drew more than 125 attendees, representing academic PET drug manufacturers, commercial PET drug manufacturers, FDA representatives, and others.
In case you missed the session, the presentations are available here:
1. Steve Zigler – Session Outline
2. Steve Mattmuller – Small Entity Perspective
3. David Wilson – Commercial Perspective
4. Michael Nazerias – Reporting Changes to Approved NDA or ANDA
5. Eric Webster – Sterility Assurance Program for PET Drugs
6. Zigler-Ravichandran – USP Update
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.