Emergency Preparedness and Response

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. 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. 

A comprehensive overview of FDA guidances is available on FDA’s Guidance Page.

View a list of MCM-related guidances by date

On this page:

General Guidances

Indication-Specific Guidances (Drugs)

Vaccines, Gene Therapies, and Cell Therapies (Biologics)

Diagnostics and Medical Devices

Other information of interest (press releases, notices, etc.)

  General Guidances

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  Indication-Specific Guidances (Drugs)

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  Vaccines, Gene Therapies, and Cell Therapies (Biologics) 

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  Diagnostics and Medical Devices

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

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Page Last Updated: 06/30/2015
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