Table 4.

FDA Contact Numbers and Resources for Emergency IND (or Individual Patient IND) Application^∗

Purpose	Resource
FDA URL for phone and fax numbers for specific drug review divisions	http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm107434.htm
General info for emergency INDs during normal business hours (8:00 am to 4:30 pm EST)	Contact CDER's DDI: Phone: 301-796-3400 or 855-543-3784 E-mail: druginfo@fda.hhs.gov
For emergency use of a specific investigational drug	Contact the review division for the drug if known, or the DDI if not known
If the DDI or review division are unknown or unavailable	Contact the CDER Emergency Coordinator of the Counterterrorism and Emergency Coordination Staff Phone: 310-796-9900 or 301-796-2210 Fax: 310-431-6356 (please call coordinator before faxing documents) E-mail: cdererops@fda.hhs.gov
After hours on weekdays, or all day on weekends	Office of Crisis Management and Emergency Operations Center Phone: 866-300-4374 or 301-796-8240

CDER = Center for Drug Evaluation and Research; DDI = Division of Drug Information; other abbreviations as in Table 3.

^∗Contact numbers are current as of March 4, 2016. Available at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126491.htm.