The Counter-Terrorism and Emergency Coordination Staff (CTECS) provides scientific, regulatory and policy assistance within the Center for Drug Evaluation and Research (CDER) for drug development initiatives relating to medical countermeasures, and coordination of emergency activities involving CDER regulated products.
What We Do
- Facilitate the development and availability of safe, effective and quality medical countermeasures (MCM) for chemical, biological, radiological and nuclear threats.
- Coordinate CDER operations and responses for emergencies involving drugs and biological therapeutics
Facilitate, coordinate, and manage the Animal Model Qualification Program (AMQP).
- Liaise with other federal partners, such as the Biomedical Advanced Research and Development Authority (BARDA), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Department of Defense (DoD).
Help scientific researchers and drug sponsors early in MCM drug development prepare for formal regulatory meetings with CDER’s review divisions.
Provide policy expertise related to Emergency Use Authorization (EUA).
- Facilitate CDER’s consistent application of the “Animal Rule.”
Guidance for Industry:
Product Development Under the Animal Rule (PDF - 2MB)
- Director: Rosemary Roberts, M.D., Rosemary.Roberts@fda.hhs.gov
- Deputy Director: Brad Leissa, M.D., Brad.Leissa@fda.hhs.gov
- Associate Director for Regulatory Affairs: Joanne Holmes, Joanne.Holmes@fda.hhs.gov
- Medical Countermeasure Development – Susan McDermott, M.D., Susan.McDermott@fda.hhs.gov
- Animal Model Qualification – Joel Beren, DVM, Joel.Beren@fda.hhs.gov
Drug Emergencies, including emergency Investigational New Drug (IND) requests – call the Office of Emergency Operations (OEO) 24-hour, 7-days-a-week emergency response system, 301-796-8240 or toll free, 1-866-300-4374