Definition

The FDA's safety information and adverse event reporting program, including Form FDA 3500A for mandatory manufacturer reporting.

Example

Pharmaceutical manufacturers submit expedited ICSRs to FDA through the MedWatch program using Form 3500A or E2B electronic transmission.

Regulatory source

FDA, 21 CFR 314.80

Common mistakes

Confusing Form 3500 (voluntary consumer reporting) with Form 3500A (mandatory manufacturer reporting).

Inspector question

Describe your MedWatch submission process. How do you handle FDA acknowledgments and requests for information?

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