On-Demand Catalog

All sessions average between 60 and 90 minutes.

Medical Device Manufacturer Requirements: An Introduction to Registration and Listing of Establishments
An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests
Regulation of Over-the-Counter (OTC) Drugs: An Introduction
An Introduction to Drug Enforcement: FDA Enforcement Authorities, Tools, Violations and Initiatives
Regulation of Drug Marketing: An Introduction
Regulation of Drug Manufacturing: An Introduction
Post Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes
The Regulation of Biologics and Biosimilars: An Introduction
The New Drug Approval Process: An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Origins and Overview of Drug Law Regulation: An Introduction

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