Frequently Requested MCMi Links
Thanks for visiting FDA’s Medical Countermeasures Initiative (MCMi). To help you find what you’re looking for, we’ve compiled a list of the most-requested content from MCMi and the FDA Office of Counterterrorism and Emerging Threats (OCET).
We’re working to improve our website. If you can’t find what you’re looking for, please send an email to AskMCMi@fda.hhs.gov.
General Information
- Medical Countermeasures Initiative
- What are Medical Countermeasures?
- About MCMi
- Office of Counterterrorism and Emerging Threats
- Pediatric Medical Countermeasures
- Medical Countermeasure Resources
- MCMi Collaborations
- Natural Disaster Response (Drugs)
- Understanding Expanded Access (Compassionate Use)
- How Drugs are Developed and Approved
- Antimicrobial Resistance Information from FDA
- Preparedness Information for Consumers
News, Events and Reports
- MCMi News and Events
- Coronavirus Disease 2019 (COVID-19)
- FDA Mpox Response
- Zika Virus Response Updates from FDA
- Ebola Preparedness and Response Updates from FDA
- MCM-Related Publications and Reports
- MCMi News Archive
- MCMi Events Archive - previous events and event materials
Information for Sponsors
- Guidances and Other Information of Special Interest to MCM Sponsors
- Guidance - Emergency Use Authorization of Medical Products and Related Authorities
- Animal Rule Information
- FDA Basics for Industry
- CDER Small Business & Industry Assistance (SBIA)
- Drug Development Tools (DDTs)
- Animal Model Qualification Program
- Animal Model Qualification: Frequently Asked Questions (FAQs)
- Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review
- Breakthrough Devices Program
- Developing Products for Rare Diseases Conditions (Orphan Products)
- Designating an Orphan Product: Drugs and Biological Products
- Device Advice: Comprehensive Regulatory Assistance
- How to Study and Market Your Device
- Data Standards Resources
Information for State, Local and Other Public Health Officials
- State, Tribal, Local, and Territorial Public Health Preparedness
- MCM-Related Legal and Policy Presentations, Publications and Q&As
- MCM Emergency Use Authorities
- Emergency Use Authorization
- Summary of Process for EUA Issuance
- Emergency Use of Approved MCMs
- Vaccine EUA Questions and Answers for Stakeholders
- FAQs: What happens to EUAs when a public health emergency ends?
- Expiration Dating Extension
- Emergency Dispensing Orders
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
- 21st Century Cures Act: MCM-Related Cures Provisions
- Summary of PAHPRA's MCM provisions
- MCM-Related Counterterrorism Legislation
- Pediatric Medical Countermeasures
- Safe Drug Use After a Natural Disaster
Information for Scientists
- MCM Regulatory Science
- Extramural Research, including BAA funding information
- Intramural Research
- Commissioner's Fellowship Program
- Advancing Regulatory Science at FDA
Information for Clinicians
- Pediatric Medical Countermeasures
- Emergency Investigational New Drug (EIND) Applications for Antiviral Products
- Expanded Access
- Physician Request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- Drug Shortages
- Safe Drug Use After a Natural Disaster
- Information Regarding Insulin Storage and Switching Between Products in an Emergency
- Contact Information for Questions about Clinical Investigations Affected by Natural Disasters
- Reporting Prescription Drug Sample Losses, Known Thefts, and Possible Diversion to the FDA in the Aftermath of a Natural Disaster
- Emergency Situations (Medical Devices)
- Medical Gowns
- Personal Protective Equipment for Infection Control
- Bioresearch Monitoring Information System (BMIS)
- Clinical Investigator Inspection List (CLIIL)
FDA's Counterterrorism Programs
- Medical Countermeasures Initiative (MCMi)
- Drugs - CDER Counter-Terrorism and Emergency Coordination Staff
- Bioterrorism and Drug Preparedness
- Biologic Product Security
- Medical Devices - Emergency Situations
- Food Defense