FDA Update: Commissioner Makary at Month Three

Join Polsinelli’s seasoned FDA practitioners and special guest, Wayne Pines, for on update on where the FDA stands now, three months after Dr. Martin Adel Makary's confirmation as the 27th FDA Commissioner.

We will discuss practical realities related to new staff reductions and return to work orders, unpack recent developments in policies and standards and provide actionable strategies for stakeholders adapting to these regulatory shifts.

Agenda

• State of FDA - staff reductions and return to work for key employees
  • Are approval dates less predictable?
  • Evidence of delays?
• What do we know about changes to vaccine, biologics and drug/device policies and standards?
• Impact of Dr. Vinay Prasad, new director of the Center for Biologics Evaluation and Research
• What should one make of the press conference on color additives?
• Strategies for stakeholders