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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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Guidances and Other Information of Special Interest to MCM Stakeholders

FDA develops guidance to provide its policy perspectives and recommendations on a wide variety of topics.
A comprehensive overview of FDA guidances is available on FDA’s Guidance Page.

The guidance documents below may be of special interest to existing or prospective medical countermeasure (MCM) sponsors, and other stakeholders, including state, tribal, local and territorial public health preparedness personnel. 

 

  General Guidances

 

  Indication-Specific Guidances

 

 

  Vaccines, Gene Therapies, and Cell Therapies (Biologics) 

 

 

  Devices (Diagnostics and Medical Devices)

 

 

Other Information of Interest (press releases, notices, etc)