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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)
Thomas W. Abrams, MBA, RPH
Retired, Director, Office of Prescription Drug Promotion, OMP, CDER, Former FDA, United States
CDER Update
CDR Roberta Szydlo, MBA, RPH, RAC
Office of Prescription Drug Promotion, CDER, FDA, United States
FDA Update: Recent Enforcement Actions and Guidances–Update on eSubDraft Guidance
Sonny Saini, PHARMD
Regulatory Health Project Manager, FDA, United States
CBER Update
Deborah Wolf, JD
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH, FDA, United States
CDRH Update
Thomas J. Moskal, DVM
Veterinary Medical Officer, FDA/CVM, United States
CVM Update
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
An Introduction to Combination Products
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