Physicians prescribing investigational drugs under expanded access must comply with FDA IND safety reporting requirements per 21 CFR 312.32. This includes immediate reporting of serious adverse events, unexpected reactions, and annual summaries. Our expert guidance helps physicians navigate complex regulatory obligations, ensuring proper documentation and timely submission of safety reports.
Patient Reporting of Adverse Events
Patients are asked to consult with their physician if they experience any adverse drug reaction or adverse event. In addition, a patient may report adverse drug reactions using the Adverse Event Report Form. Please return the completed form by email or fax as indicated at the top of the form.
- The new Consumer Form FDA 3500B is found here.
Adverse Event Reporting by Health Care Providers
To report an adverse drug reaction (ADR) or adverse event (AE), please download the Adverse Event Report Form. Please return the completed form by email or fax as indicated at the top of the form.
- FDA Form 3500a (SAE Reporting for Individual IND Expanded Access)
- (FDA FAX number (800) 332-1088 or email: fda.gov/medwatch/report.htm)