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Medical Devices

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations

About the Course

This online 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 eLearning course provides an overview of PADE regulations, guidance, inspectional candidate selection, inspectional techniques and regulatory actions to enhance the field investigator’s knowledge. The compliance course 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.