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.
We’re working to improve our website. If you can’t find what you’re looking for, please send an email to ORES@fda.hhs.gov.
General Information
- Medical Countermeasures Initiative
- What are Medical Countermeasures?
- About MCMi
- 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
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)