Existing Accelerated CMC, Advanced Manufacturing, and Inspection Initiatives are Supporting Regulators in Pandemic Response, FDA’s Cruse Explains in Recent Field Office Updates

Initiatives that the major regulatory agencies have been advancing to help address the CMC and technology challenges of developing complex medicines under accelerated timelines are creating a critical foundation for responding to the current coronavirus pandemic.

Also providing regulators with additional valuable tools in their pandemic response are collaborative initiatives that have been put in place to improve global inspection and supply chain monitoring.

Appearing as a keynote speaker at a series of public conferences in March, FDA Office of Regulatory Affairs (ORA) Office of Pharmaceutical Quality Operations Director Alonza Cruse offered insights on how these regulatory initiatives – and the intra-agency and international collaboration they entail – are supporting FDA’s response to the coronavirus pandemic.

Cruse’s series of presentations began at the International Society of Pharmaceutical Engineering (ISPE) Aseptic Conference on March 2-3. He then appeared as the lead-off speaker at the University of Georgia/FDA International GMP Conference held the next week in Athens, GA. Another keynote talk followed at the March 18-20 Xavier/FDA PharmaLink conference, which shifted to being held virtually.

This shift was reflective of the increasing global impact of the pandemic during these three weeks. With the adjustments FDA was making due to the rapidly evolving pandemic situation during this timeframe, Cruse was able to provide a fuller picture of the regulatory impact and response at the latter conference.

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