Drug Safety and Pharmacovigilance Across the Product Lifecycle
Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.
Session 18: FDA Warning Letters
Jill W. Buckley, PharmD
- Adjunct Assistant Professor
- Rutgers, the State University of New Jersey, United States
A review of recent findings from several FDA Post-Marketing Adverse Drug Experience inspections will be discussed using Warning Letters to identify observations.