SNMMI Co-hosts Workshop at FDA on Inspections Management and Regulatory Considerations

February 24, 2020

Sally Schwarz, RPh, speaks about current trends and observations on inspections.

On Friday, February 21, SNMMI and the Food and Drug Administration (FDA), 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" at the FDA White Oak Conference Center in Silver Spring, MD.

The workshop featured four sessions on different aspects of the FDA process, each ending with a panel discussion. Sessions were presented by a combination of nuclear medicine/molecular imaging professionals, industry representatives, and FDA representatives.

The workshop opened with welcoming remarks from Sally Schwarz, RPh, Henry VanBrocklin, PhD, Sue Bunning, MA, and Louis Marzella, MD, PhD.

The first session, “Considerations and Trends in Inspections and Compliance,” moderated by Steve Zigler, PhD, and Krishna Ghosh, PhD, included information about the manufacturing process and pre-approval inspections, PET surveillance cGMP inspections, current trends, and the FDA Pilot Program for tablet-based inspections.

The second session, “Lifecycle Management of PET Drug Applications,” moderated by Peter Scott, PhD, and Ramesh Raghavachari, PhD, covered the management of NDAs and ANDAs and the PET community perspective.

Session 3 on “Chemistry and Product Quality Assurance," moderated by Steve Mattmuller, RPh, BCNP, and Ravi Kasliwal, PhD, included presentations on the microbiological regulatory perspective, sterility assurance, and product quality assurance.

The final session, “Changing Landscape of PET Drugs, Labeling Requirements, and Electronic Filing Requirements,” was moderated by Michael Nazerias, MS, and Louis Marzella, MD, PhD, and covered the landscape for PET drugs, labeling requirements for NDAs, and requirements for electronic filing of regulatory applications.

Bringing all stakeholders together will improve the global understanding of regulatory and compliance topics associated with PET drug manufacturing. Thank you to all SNMMI members sharing their expertise and experience today, including: Christopher Ignace, PharmD, PhD; Steve Mattmuller, MS, RPh, BCNP; Michael Nazerias, MS; Sally Schwarz, MS, RPh, BCNP, FAPhA; Peter Scott, PhD; Henry F. VanBrocklin, PhD, FSNMMI; Peter J. Webner, CNMT, RT(N); and Steven Zigler, PhD.