On-Demand Catalog

All sessions average between 60 and 90 minutes.

Regulation of Over-the-Counter (OTC) Drugs: An Introduction
The Regulation of Biologics and Biosimilars: An Introduction
Post Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes
An Introduction to the Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
The New Drug Approval Process: NDA Submission and Review
The New Drug Approval Process: New Drug Research and Development
The New Drug Approval Process: Basic Concepts
Origins and Overview of Drug Law Regulation: An Introduction
Stabilizing After the Stabilization Period: What to Expect From Further Implementation of DSCSA
International Issues for Medical Device Manufacturers: An Introduction

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