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  1. MCM Legal, Regulatory and Policy Framework

Guidance and Other Information of Special Interest to MCM Stakeholders

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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. 

Search all FDA guidance FDA guidance overview MCM-related guidance by date 

For additional guidance and industry announcements from previous years, please visit our archives, available by topic and by date.
On this page:

General Guidance

Indication-Specific Guidance (Drugs)

Vaccines, Gene Therapies, and Cell Therapies (Biologics)

Diagnostics, Medical Devices and Personal Protective Equipment (PPE)

Pediatric Guidance of Interest to MCM Stakeholders

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

General Guidance

2020 (including items with comment deadlines in 2020)

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Indication-Specific Guidance (Drugs)

2020 (including items with comment deadlines in 2020)

  • December 2019: Draft guidance - Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff - Provides FDA’s current thinking regarding the qualification process for drug development tools (DDTs) for a specific use, as defined in the 21st Century Cures Act. Qualification is a voluntary process that permits use of a DDT for its context of use— the defined boundaries within which the available data justifies use of the DDT(s)—across multiple drug development programs. DDTs are methods, materials, or measures that have the potential to facilitate drug development, including, for example, an animal model used for efficacy testing of medical countermeasures under the Animal Rule. Comment by February 12, 2020.

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Vaccines, Gene Therapies, and Cell Therapies (Biologics) 

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Diagnostics, Medical Devices and Personal Protective Equipment (PPE)

2020

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Pediatric Guidances of Interest to MCM Stakeholders

Also see the Pediatric Medical Countermeasures guidance page from CDER, including considerations for bioterrorism and radiation emergencies.

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

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