Early Access Care helps patients and their physicians work through the process of requesting compassionate use of investigational drugs.
Physician IND Safety Reporting
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 1-800-332-1088 or email: www.fda.gov/medwatch/report.htm )