FDA Representatives to Discuss Impact of DQSA in Special Plenary at PDA Micro Conference

This fall marks the fifth anniversary of the New England Compounding Center meningitis outbreak. In recognition of this tragedy and the importance of ensuring microbial control, three U.S. FDA representatives have been confirmed to speak in a special plenary session at this year’s 12th Annual PDA Global Conference on Pharmaceutical Microbiology. Moderated by CDER’s John W. Metcalfe, PhD, Plenary 4, “FDA Update on Human Drug Compounding: Regulatory Policy and Drug Quality” (Tuesday, Oct. 17, 4:15 p.m.), will feature the following FDA staff:

• Julie Dohm, PhD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER
• Sara Rothman, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, CDER
• Ian F. Deveau, PhD, Chief, Global Compliance Branch 1, Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance, CDER

All three will discuss the 2013 Drug Quality and Security Act (DQSA) and its impact on FDA’s oversight of compounding facilities. To learn more, visit the website for the conference.