Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations

This course on the Postmarketing Adverse Drug Experience Reporting Program (PADE) represents CDER’s current thinking on how field postmarketing ADE reporting inspections support CDER’s drug safety surveillance activities. The course provides an overview of PADE regulations, guidance, inspectional candidate selection, inspectional techniques and regulatory actions to enhance the field investigator’s knowledge. It discusses how CDER's medical reviewers and safety evaluators track drug products for potential safety signals and how the field investigators determine if drug firms are providing FDA with complete, accurate, and timely safety data necessary for this evaluation.