Drug Law: Understanding the Essentials of FDA's Authority over Innovative and Generic Pharmaceuticals: 2-day In-Person Seminar

Course Description:

FDA authority over both innovative and generic pharmaceuticals is not only pervasive, but imposes duties on industry that, if not followed, expose drug companies and their officials to severe penalties, up to and including criminal prosecution.

This two day interactive course will review the foundations for FDA’s authority over pharmaceutical companies and will focus on the three central roles of the FDA relative to drug companies. These include: FDA serving as the gatekeeper to the marketplace, primarily through the drug approval process; the agency’s status as the “cop on the beat” that enforces the FDA’s requirements through both administrative actions (e.g., warning letters) and judicial proceedings such as seizures, injunctions and criminal prosecutions; and, finally, the FDA serves as the sentinel of health issues through its role in overseeing industries’ reporting of adverse events through the process referred to generally as pharmacovigilance.

To ensure your firm does not run afoul of the FDA’s requirements, a detailed understanding of those duties is essential. Attendees at this seminar will leave with the tools necessary to help ensure their companies stay in the agency’s good graces, so they can continue to succeed in the marketplace.