Speakers

CAPT Sigler serves as the Deputy Director, Division of Project Management in the Office of Regulatory Operations in the Office of Generic Drugs (OGD). He previously served in OGD as a Supervisory Project Manager and a Project Manager in the Division of Bioequivalence since joining the FDA in 2002. In addition to his duties in the Division, he has held several positions within the Office, including assistance with the GDUFA III Commitment Letter creation and evaluation, numerous Office leadership councils, and process improvement work groups. He mentors pharmacy interns and new employees and lectures to various groups regarding generic drugs. Prior to joining the USFDA, he served 6 years in the U.S. Navy as a pharmacist in various roles at the National Naval Medical Center, as well as Pharmacy Department Head at the Naval Medical Clinic, Marine Corps Base Quantico. He received his B.S. and Pharm.D. degrees from the St. Louis College of Pharmacy and completed a residency in Pharmacy Practice at the National Naval Medical Center.

The Office of Generic Drugs is responsible for regulating the generic drug applications submitted by the generic drug industry. This encompasses regulatory, scientific, and testing activities. The 68 members of the Division of Project Management (DPM) are responsible for overseeing the timely triage, review, and processing of these applications. Additionally, DPM staff members are the liaison between both internal and external stakeholders regarding information and meeting communications.