Doctors may contact the FDA by phone, fax or email to seek approval for emergency use of an investigative drug, but a phone call is best after hours, the agency says, in a newly updated policy manual.
The FDA doesn’t necessarily monitor incoming emails and faxes outside its working hours of 8 a.m. to 4 p.m. ET, Monday through Friday, but CDER’s emergency call center is active round the clock.
During normal business hours, doctors should contact the appropriate review division of the Office of New Drugs, or the Division of Drug Information, for expanded-access approvals, the manual says. The ultimate resort day or night is the CDER emergency coordinator (CEC) on duty.