FDA’s Role in Preventing and Mitigating Drug Shortages
1:30 p.m. - 3:00 p.m.
There appears to be much confusion about what is driving drug shortages, and what is a true drug shortage versus an out-of-stock situation. This session will explore FDA’s role in preventing and responding to drug shortages as well as what the healthcare ecosystem may encounter in the near future if efforts to understand and effectuate changes to this complex framework are not addressed.
CAPT Christine Bina, RPh, MPH
Team Leader, Drug Shortage Staff, OCD, CDER, FDA
Ryan Conrad, PhD
Economist, Economics Staff, OPSA, OSP, CDER, FDA
Bhupesh Singh, MPharm
Director, Regulatory Affairs US, Apotex Corp.
Andrew Coogan, PharmD, BCPS
Drug Shortage Coordinator, Division of Legal and Regulatory Support, OGDP, OGD, CDER, FDA
Jennifer Maguire, PhD
Director, Office of Quality Surveillance, OPQ, CDER, FDA
Scott Kuzner, PhD
Senior Director, Sciences and Regulatory Affairs, AAM