Drug Products FDA Regulatory Overview

BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the regulatory paths associated with drug products; from pre-clinical work leading to the Investigational New Drug (IND) application, and to the New Drug Application (NDA) submission leading to successful registration.

Drug products in the U.S. are regulated by the Center for Drug Evaluation and Research (CDER).  CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.  Included in this regulatory overview are the descriptions of the types of submissions for approval including the NDA, the Abbreviated New Drug Application (ANDA) for generic drugs, and the 505(b)(2) for modifications to previously approved drugs (including expanded label claims).