DSE #5 – Investigational New Drug Exemption
Podcast #5 focuses on how the Investigational New Drug Exemption, which is known as the IND, relates to the adverse events and toxicology of new drugs. Steven Baranowitz, MD MS MBA of Drug Safety Expert Associates gives an overview of this important information.
Standard Podcast [2:24m]: DSE #4 – Sources for Documentation of Drug Adverse Events
Podcast #4 discusses which FDA documents submitted by pharmaceutical companies contain information on adverse events. Steven Baranowitz, MD MS MBA of Drug Safety Expert Associates gives an overview of this important information.
Standard Podcast [3:30m]: DSE #3 – Expedited Reporting in Clinical Trials
Podcast #3 discusses how “expedited” reports are evaluated for submission to FDA regarding drugs in clinical trials (before they are available to the general public). Steven Baranowitz, MD MS MBA of Drug Safety Expert Associates provides a concise introduction to this complex topic.
Podcast #3 - Expedited Reporting in Clinical Trials [2:44m]: DSE #2 – Expedited Reporting
Podcast #2 presents the concept of “expedited” reporting to FDA of adverse events occurring in drugs presently on the market. Steven Baranowitz, MD MS MBA of Drug Safety Expert Associates provides the essential facts.
Expedited Reporting [3:30m]: DSE #1 – Introduction to Drug Safety
In this series of podcasts, evaluation of Drug Safety for compliance with FDA regulations is introduced by Steven Baranowitz, MD MS MBA of Drug Safety Expert Associates. In Podcast #1, the concepts, regulations, and terminology for adverse event reporting in the United States are discussed. The classification of “serious” adverse experiences is reviewed, and the meaning of “unexpected” adverse events is explained.
Intro to Drug Safety [3:30m]: