FDA Names New Office of Generic Drugs Director
In an email to staff on Tuesday, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced that Sally Choe will take over for Kathleen Uhl as Director of the Office of Generic Drugs (OGD) upon Uhl’s retirement at the end of the month after serving more than 20 years at the agency.“With more than 18 years of experience in global drug development, Sally is an accomplished leader in both government and the private sector. She is a recognized expert in drug review, clinical pharmacology, biopharmaceutics and pharmacokinetics – with a reputation for advancing innovation, scientific excellence and staff development,” Woodcock said.
Choe, who currently serves as the deputy director of the Office of Study Integrity and Surveillance (OSIS) within the Office of Translational Sciences (OTS), returned to agency in 2017 after a six-year stint as a senior director at Parexel overseeing the firm’s Asia-Pacific and Japan offices.
Prior to that, Choe spent six years as a team leader for metabolism and endocrinology products at FDA’s Office of Clinical Pharmacology after working for both Pfizer and Bristol-Myers Squibb.
Choe’s appointment as OGD Director comes as FDA continues to see high levels of generic drug approvals. For each of the past three fiscal years, FDA has broken its record for the number of abbreviated new drug applications it has approved or tentatively approved. FDA Commissioner Scott Gottlieb has also made the approval of generic drugs a priority for the agency as part of its efforts to spur competition and address rising prescription drug costs.