PDA Letter Article

A Glimpse at FDA’s Micro Regulations

by Rebecca Stauffer, PDA

The 2019 PDA Global Conference on Pharmaceutical Microbiology closed with an engaging “Ask the Regulators” panel. Yeissa Chabrier-Rosello, PhD, Microbiologist, CDER, U.S. FDA, and John W. Metcalfe, PhD, Master Microbiology Reviewer, CDER, FDA, moderated the panel of FDA experts, which featured John T. Arigo, PhD, Branch Chief, CDER, Reyes Candau-Chacon, PhD, Quality Assessment Lead, CDER, Rick L. Friedman, Deputy Director, OMQ, CDER, Anthony F. Lorenzo, Lead Consumer Safety Officer, CBER, and J. Kevin Rice, PhD, Review Chemist, CVM.

Throughout the conference, attendees could submit questions on cards to be read during the session. This is a popular session of the microbiology conference, and, if you missed it, consider attending the 15th Annual Global Conference on Pharmaceutical Microbiology, Oct. 19–21, in Washington, D.C.

The following is a lightly edited transcript of the session with the identities of the questioners hidden. The panelists were given an opportunity to review their answers.

[Editor's Note: This is an abridged summary of FDA responses during a panel dialogue at a conference. The responses below are an informal synopsis of the panel's opinions and should not be construed to represent FDA’s views or policies.]