Medical Countermeasures Initiative (MCMi)

-- Protecting National Health and Security

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 In the Headlines

• The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), enacted on March 13, 2013, provides key legal authorities to sustain and strengthen national preparedness for public health emergencies. For more information, continue reading ...  

 

• 2013 MCMi Regulatory Science Symposium: May 29-31  
   

 

 

 

 

 

 

• April 22, 2013: H7N9 Influenza Emergency Use Authorization (Potential Emergency)
  On April 22, 2013, FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA-cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. CDC will distribute this device to public health- and other qualified laboratories.
• MCMi awards Regulatory Science grant to Stanford University

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About MCMi
The nation's Public Health Emergency Medical Countermeasures Enterprise identified FDA as one of its most critical components.  Strong and dynamic FDA engagement with Enterprise partners will establish clear regulatory pathways for product innovators--based on the most advanced science--and will ultimately accelerate MCM development.

Within FDA's Office of the Chief Scientist, the Office of Counterterrorism and Emerging Threats is responsible for leading the implementation of the Medical Countermeasures Initiative in close collaboration with FDA's three medical product centers--CDER, CBER, and CDRH--and the Office of Regulatory Affairs.
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