FDA highlights regulatory science collaborations aimed at emergency preparedness efforts

The Federal Drug Administration’s FDA Voice publication recently highlighted collaborations between regulatory organizations in the science community that enhance emergency preparedness efforts

Director of Regulatory Science Programs in the FDA's Office of Counterterrorism and Emerging Threats Jean Hu-Primmer outlined several collaborations in the FDA Voice publication – like the FDA Medical Countermeasures Initiative (MCMi) that involves federal agencies, researchers, health care professionals and other partners to create effective medical countermeasures from current science and technology measures.

The FDA and the Biomedical Advanced Research and Development Authority (BARDA) are working together to evaluate how medical products can save people during public health emergencies and to work with critical care physicians to overcome challenges related to public health emergencies.

The FDA/BARDA collaboration will undertake a four-year project with the U.S. Critical Illness and Injury Trials Group (USCIITG) to look at the challenges of streamlining electronic case reporting. USCIITG will, in the 2015-2016 flu season, develop an influenza treatment protocol in 10 U.S. hospitals to help doctors use the investigational protocol with patients who have severe influenza.

Hu-Primmer also highlighted that BARDA is giving USCIITG funds for phase 4 clinical studies of drugs approved under the Animal Rule; MCMi also received two regulatory science contracts for emergency preparedness projects regarding decontamination and reuse of respirators in public health emergencies.

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U.S. Food and Drug Administration (FDA)

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