Contacting the Manufacturer

For all types of investigational medical products, the FDA requires that the clinician contact the manufacturer to see if they will provide the investigational medical product for expanded access use. The manufacturer may provide the investigational medical product for use under its own IND or IDE.

If no IND for use of a drug or biologic exists, the clinician may need to obtain their own IND; however, the FDA may authorize shipment of a drug or biologic in advance of an IND submission in an emergency.

For devices, the FDA does not require the clinician to obtain an IDE in emergency use situations if one does not already exist. See “E-Use: Initial Notification to the FDA” for contact information for the FDA.

Contacting the Pharmaceutical Research Center (PRC)

For emergency use of a drug or biologic only, the clinician must contact the PRC for assistance (608.263.8902).