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Session 5: FDA Update: Recent Enforcement Actions and Guidances
Session Chair(s)
Wayne Pines
President, Health Care
United States
Are you aware of all of the current issues, laws, and new guidances regarding the promotion of prescription drugs, biologics and medical devices? In this session, FDA panelists will review the latest on policy development, enforcement and the FDA’s future initiatives as well as the new guidances that describe the FDA’s current thinking on important issues that have been raised by industry and the FDA’s recommendations in these areas.
Speaker(s)
CDER Update
Thomas W. Abrams, MBA, RPh
Former FDA, United States
Retired, Director, Office of Prescription Drug Promotion, OMP, CDER
FDA Update: Recent Enforcement Actions and Guidances–Update on eSubDraft Guidance
CDR Roberta Szydlo, MBA, RPh, RAC
FDA, United States
Office of Prescription Drug Promotion, CDER
CBER Update
Sonny Saini, PharmD
FDA, United States
Regulatory Health Project Manager
CDRH Update
Deborah Wolf, JD
FDA, United States
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH
CVM Update
Thomas J. Moskal, DVM
FDA/CVM, United States
Veterinary Medical Officer
An Introduction to Combination Products
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
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