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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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MCMi FY 2013: MCMi Fiscal Year 2013 Program Update

 

FDA MCMi Fiscal Year 2013 Program Update 

MCMi FY 2013: MCMi Fiscal Year 2013 Program Update

 

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), enacted in 2013, requires FDA to issue an annual report detailing its medical countermeasure activities. This report responds to that requirement for Fiscal Year 2013.

 

View contents of the report using the links below, or download a printable PDF (1.3 MB). Footnotes are denoted throughout the text with numbers in parentheses; the corresponding footnote appears at the bottom of each section or page.

 

Table of Contents 

Message from Luciana Borio, MD, Assistant Commissioner for Counterterrorism Policy

BackgroundReport cover: MCMi Fiscal Year 2013 Program Update

FY 2013 Medical Countermeasure Resources

FY 2013 Objectives, Activities, and Achievements

Objectives and Activities

Medical Countermeasure Approvals

Supporting an Adequate Supply of Medical Countermeasures

Enabling Access to Available Medical Countermeasures

Responding to Emerging Public Health Threats

Facilitating Medical Countermeasure Development

Collaborations

Medical Countermeasure Regulatory Science

Medical Countermeasure Regulatory Policy

Professional Development

Appendix 1: FY 2013 Medical Countermeasure Approvals

Appendix 2: Acronyms

 

List of Tables

Table 1: FY 2013 Resources Obligated to Medical Countermeasure Activities

Table 2: FY 2013 Formal Meetings Between CBER/CDER and Medical Countermeasure Sponsors or Applicants

Table 3: FY 2013 Formal Meetings Between CDRH and Medical Countermeasure Sponsors or Applicants

Appendix 1: FY 2013 Medical Countermeasure Approvals - Biologics

Appendix 1: FY 2013 Medical Countermeasure Approvals - Drugs

Appendix 1: FY 2013 Medical Countermeasure Approvals - Devices