MCMi Newsletters
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FDA’s Medical Countermeasures Initiative (MCMi) is an agency-wide initiative to coordinate medical countermeasure development, preparedness and response to help protect the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats.
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Previous editions
Note that links in previous editions may no longer be active.
2022
- October 19, 2022: Public health emergency response news from FDA | Regulatory science & funding updates
- October 12, 2022: FDA authorizes bivalent COVID-19 vaccine boosters in younger age groups | First commercial test kit for detection of monkeypox
- October 5, 2022: Latest updates about Evusheld for PrEP for COVID-19
- September 28, 2022: FDA updates COVID-19 test policy | New printable COVID-19 vaccine wall charts including bivalent boosters
- September 21, 2022: New webinar series for monkeypox test developers starts today | Save the date for BAA Industry Day + more news & events
- September 14, 2022: FDA takes significant action to help expand access to monkeypox testing | COVID-19 response updates from FDA
- September 7, 2022: What is a bivalent vaccine? +more COVID-19 booster info, and September/October events
- August 31, 2022: FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose | Media call today at 10:45 a.m. ET
- August 24, 2022: Check your COVID-19 test expiration dates | Monkeypox response updates from FDA
- August 17, 2022: COVID-19 and monkeypox response updates from FDA | Monkeypox vaccine fact sheet in multiple languages
- August 10, 2022: Public health emergency response updates from FDA: COVID-19 and monkeypox updates
- July 20, 2022: COVID-19 response updates from FDA | Monkeypox testing safety communication
- July 13, 2022: FDA authorizes pharmacists to prescribe Paxlovid | Advanced manufacturing job openings
- July 6, 2022: COVID-19 vaccine and therapeutic updates | FDA seeking consumer representatives for advisory committees
- June 29, 2022: Updates from FDA on COVID-19 medical countermeasures, monkeypox testing, advanced manufacturing, and more
- June 22, 2022: FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines for children down to 6 months of age
- June 15, 2022: First COVID-19 test to identify specific SARS-CoV-2 lineages authorized
- June 8, 2022: COVID-19 updates from FDA | Collaborating to enhance testing capacity during public health emergencies
- June 1, 2022: June event updates: vaccine advisory committees, register now for July course on clinical trials involving high-consequence pathogens
- May 25, 2022: Updated vaccine advisory committee dates | Know your treatment options for COVID-19
- May 18, 2022: FDA expands eligibility for Pfizer-BioNTech COVID-19 Vaccine booster dose to children 5 through 11 years
- May 11, 2022: COVID-19 response updates from FDA: vaccines, tests, treatments, regulatory science & more
- May 4, 2022: COVID-19 at-home test updates: expiration date extensions, watch out for counterfeit tests
- April 27, 2022: FDA approves first COVID-19 treatment for young children
- April 13, 2022: FDA authorizes more OTC at-home COVID-19 tests | Shelf life extension for a COVID-19 vaccine
- April 6, 2022: EUA updates and FAQs | Watch live today: VRBPAC meeting
- March 30, 2022: FDA authorizes second booster dose of two COVID-19 vaccines for ages 50+ and immunocompromised individuals
- March 23, 2022: COVID-19 test safety information | MCMi job alert: Regulatory counsel
- March 16, 2022: New Medical Countermeasures Initiative report and COVID-19 response infographic
- March 9, 2022: More video FAQs on COVID-19 vaccines | Regulatory science update: 3D tissue chips
- March 2, 2022: COVID-19 testing updates | Revisions to COVID-19 therapeutic EUAs
- February 23, 2022: New resource on at-home OTC COVID-19 tests | MCMi job alert: Interdisciplinary scientist
- February 16, 2022: FDA authorizes new monoclonal antibody that retains activity against omicron | Feb. 22 webinar on transition plans for COVID-19 medical devices
- February 9, 2022: COVID-19 test safety alert | Using real-world evidence to advance COVID-19 medical countermeasures
- February 2, 2022: FDA approves 2nd COVID-19 vaccine | Feb. 15 advisory committee scheduled
- January 26, 2022: FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 | At-home diagnostic test updates
- January 19, 2022: Video FAQs about COVID-19 vaccines | Apply by Jan. 21 for regulatory science funding
- January 12, 2022: COVID-19 response updates: tests, vaccines, events, and more
- January 5, 2022: Boosters are now authorized for people 12 years of age and older
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December 30, 2021: FDA authorizes first two oral antivirals for treatment of COVID-19 | EUA updates for COVID-19 treatments and tests
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December 22, 2021: Are you eligible for a booster? | Strengthening coronavirus models with systems biology and machine learning
- December 15, 2021: FDA authorizes new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals | COVID-19 vaccine updates
- December 8, 2021: Impact of omicron variant on COVID-19 tests | Monoclonal antibodies for younger pediatric patients
- December 1, 2021: FDA actively working to investigate, address potential impacts of omicron variant
- November 23, 2021: FDA expands eligibility for COVID-19 vaccine boosters to individuals 18 and older after completion of primary vaccination | Regulatory science funding available
- November 19, 2021: MCMi news alert: Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters
- November 17, 2021: FDA updates COVID-19 testing policies to help ensure accuracy and reliability, increase access to at-home tests
- November 10, 2021: Fighting COVID-19 with science | More OTC diagnostic tests authorized
- November 3, 2021: COVID-19 vaccine authorized for 5-11-year-olds | FDA investigating certain imported medical gloves
- October 27, 2021: Increasing availability of over-the-counter COVID-19 tests | Are you eligible for a COVID-19 booster shot?
- October 20, 2021: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
- October 13, 2021: COVID-19 vaccine myths: busted
- October 6, 2021: FDA authorizes additional OTC home test to increase access to rapid testing | More COVID-19 response updates from FDA
- September, 29, 2021: It’s a good time to get your flu shot | COVID-19 response updates from FDA
- September 22, 2021: Join us for a public workshop on COVID-19 therapeutics lessons learned Sept. 28 | More COVID-19 response updates from FDA
- September 8, 2021: Are you prepared for an emergency? | COVID-19 response updates from FDA
- September 1, 2021: Get the facts about COVID-19 vaccines and treatments in multiple languages | Important alert for veterinarians and animal drug retailers
- August 25, 2021: More about the first FDA COVID-19 vaccine approval | EUA and shelf-life extension updates
- August 18, 2021: 5 things you need to know about the COVID-19 vaccine for adolescents 12 through 17
- August 4, 2021: COVID-19 treatment updates | New vaccine FAQs
- July 21, 2021: COVID-19 updates | Register now to learn about clinical trials involving high-consequence pathogens
- July 14, 2021: Hear from FDA leaders on Emergency Use Authorization | COVID-19 vaccine updates
- July 7, 2021: FDA revokes EUAs for non-NIOSH-approved disposable respirators and decontamination systems | COVID-19 vaccine videos in more languages
- June 30, 2021: FDA authorizes drug for treatment of COVID-19 | Use hand sanitizer in a well-ventilated area
- June 16, 2021: FDA takes steps to increase availability of COVID-19 vaccine
- June 9, 2021: FDA approves drug to treat smallpox | Strengthening the pharmaceutical supply chain | Your EUA questions answered
- June 2, 2021: COVID-19 updates: new monoclonal antibody authorized, variant update, safety communication + more
- May 26, 2021: Join the FDA Science Forum today | New MCMi report, including FDA COVID-19 response snapshot
- May 19, 2021: COVID-19 updates from FDA | Register for the FDA Science Forum
- May 12, 2021: FDA authorizes Pfizer-BioNTech COVID-19 Vaccine for emergency use in adolescents
- May 5, 2021: Safely using hand sanitizer + more COVID-19 response updates from FDA
- April 28, 2021: COVID-19 vaccine updates from FDA
- April 21, 2021: COVID-19 vaccine FAQ updates | #VaccineReady toolkit | New streamlined Emergency Use Authorization approach for serial testing
- April 14, 2021: Ensuring the safety and quality of COVID-19 vaccines | Registration open for training: Achieving Data Quality & Integrity in Maximum Containment Laboratories
- March 31, 2021: Learn more about COVID-19 vaccines | Emergency Use Authorization (EUA) updates
- March 24, 2021: How you can help stop COVID-19
- March 17, 2021: Know your COVID-19 treatment options | New adverse event reporting dashboard
- March 10, 2021: Why you should not use ivermectin to treat or prevent COVID-19 | Beware of misleading registration certificates | New COVID-19 tests authorized
- March 3, 2021: Third COVID-19 vaccine authorized for emergency use | New at-home COVID-19 test
- February 27, 2021: MCMi news alert: FDA issues EUA for third COVID-19 vaccine
- February 24, 2021: COVID-19 updates: vaccine safety surveillance, policies to address virus variants, Feb. 25 health equity webinar
- February 10, 2021: COVID-19 therapeutics resources and a new authorization | Update on variants | Vaccines advisory committee scheduled for Feb. 26
- February 3, 2021: Q&A on COVID-19 vaccines | Radiation treatment approved
- January 27, 2021: New collaboration to increase advanced manufacturing for medical countermeasures | Updates on respirator decontamination systems, new guidances, and more
- January 13, 2021: Moderna COVID-19 Vaccine FAQs | SARS-CoV-2 viral mutation alert for health care and laboratory staff
- January 6, 2021: Risk of false results with the Curative SARS-CoV-2 test for COVID-19 | New hand sanitizer toolkit | 2020 at FDA
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December 30, 2020: COVID-19 vaccine EUA updates: new FAQs and fact sheet translations
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December 21, 2020: FDA authorizes 2nd COVID-19 vaccine | Vaccine information now available in multiple languages | FDA approves Ebola therapeutic
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December 18, 2020: MCMi news alert: FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
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December 16, 2020: FDA issues EUA for first COVID-19 vaccine | First over-the-counter fully at-home test authorized
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December 12, 2020: MCMi news alert: FDA issues EUA for first COVID-19 vaccine
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December 9, 2020: Watch vaccine advisory committee meetings live Dec. 10 and 17
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December 2, 2020: Emergency Use Authorization for vaccines explained | Additional COVID-19 treatments authorized
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November 18, 2020: COVID-19 response updates from FDA: First COVID-19 test for self-testing at home | A closer look at COVID-19 diagnostic testing
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November 10, 2020: COVID-19 updates from FDA: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19
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November 4, 2020: COVID-19 updates from FDA: What to know about at-home oxygen therapy | Essential medicines, medical countermeasures, critical inputs
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October 28, 2020: COVID-19 updates: FDA approves first treatment for COVID-19
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October 21, 2020: COVID-19 updates from FDA | First FDA-approved Ebola virus treatment | About advisory committees
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October 14, 2020: COVID-19 updates from FDA | Antimicrobial resistance paper & public meeting
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October 7, 2020: COVID-19 updates from FDA: New COVID-19 vaccines page and guidance | SARS-CoV-2 research | Emergency Use Authorization updates
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September 30, 2020: COVID-19 updates from FDA: First point-of-care antibody test for COVID-19 | New patient outreach toolkit
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September 23, 2020: COVID-19 updates from FDA: Beware of fraudulent coronavirus tests, vaccines, and treatments
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September 16, 2020: FDA's oversight of COVID-19 vaccines | New global coronavirus research project | Performance data for COVID-19 diagnostics
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September 9, 2020: COVID-19 updates from FDA: Multilingual resources for consumers | Convalescent plasma guidance update
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September 2, 2020: Watch out for hand sanitizers packaged in food and drink containers | First rapid COVID-19 test where results can be read directly from testing card (PDF, 151 KB)
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August 26, 2020: COVID-19 updates from FDA: Emergency Use Authorization for convalescent plasma | Is your hand sanitizer on FDA's list of products you should not use (PDF, 166 KB)
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August 19, 2020: COVID-19 updates from FDA: More hand sanitizers consumers should not use | Device shortages during the COVID-19 public health emergency (PDF, 140 KB)
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August 12, 2020: COVID-19 updates from FDA | FDA Commissioner message to health care providers | Coronavirus Treatment Acceleration Program updates (PDF, 141 KB)
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August 5, 2020: COVID-19 updates from FDA | Investing in advanced manufacturing to support public health preparedness | Donate COVID-19 plasma (PDF, 196 KB)
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July 29, 2020: Hand sanitizer safety alert | First test authorized to screen people without known or suspected COVID-19 infection (PDF, 142 KB)
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July 22, 2020: COVID-19 response updates from FDA | Protecting patients and consumers from fraud (PDF, 146 KB)
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July 15, 2020: Behind the Scenes: How FDA is Working to Facilitate COVID-19 Treatments (PDF, 150 KB)
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July 8, 2020: Coronavirus response updates from FDA - hand sanitizer and Emergency Use authorization updates, and a new podcast on food safety (PDF, 158 KB)
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July 1, 2020: Coronavirus response updates from FDA - vaccine development, Emergency Use authorization updates, and a new podcast on testing (PDF, 140 KB)
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June 24, 2020: 3D Printing in FDAs Rapid Response to COVID-19 | Updates for health care providers and industry on testing, device shortages, and more (PDF, 150 KB)
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June 17, 2020: COVID-19 Emergency Use Authorization updates on drug products and tests (PDF, 140 KB)
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June 10, 2020: An introduction to COVID-19 tests | Emergency Use Authorization updates on ventilators, respirator decontamination, antibody tests | Testing supply substitution strategies (PDF, 144 KB)
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June, 3, 2020: Understanding terminology of potential COVID-19 medical countermeasures | COVID MyStudies App | Reference panel for COVID-19 test developers (PDF, 273 KB)
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May 27, 2020: Coronavirus antibody test transparency | Emergency Use Authorization updates + more (PDF, 130 KB)
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May 20, 2020: Coronavirus testing basics | Supply chain update | First standalone at-home sample collection kit authorized (PDF, 141 KB)
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May 13, 2020: New Emergency Use Authorization templates and firsts | Bilingual social media toolkit | Masks: working with FDA (PDF, 160 KB)
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May 6, 2020: FDA issues Emergency Use Authorization for potential COVID-19 treatment, updates antibody test policy (PDF, 146 KB)
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April 29, 2020: Coronavirus response updates | FDA provides flexibility to food industry to meet consumer demand during COVID-19, Emergency Use Authorizations + more (PDF, 162 KB)
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April 22, 2020: FDA’s actions in response to coronavirus disease | Shopping for food during the COVID-19 pandemic | Coronavirus Treatment Acceleration Program (PDF, 186 KB)
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April 15, 2020: FDA’s actions in response to coronavirus disease | How you can make a difference (PDF, 142 KB)
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April 8, 2020: FDA’s actions in response to coronavirus disease | FDA Commissioned Corps Officers on the Front Line (PDF, 120 KB)
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April 1, 2020: FDA’s actions in response to coronavirus disease | More Emergency Use Authorizations | 3D printing during COVID-19 (PDF, 95 KB)
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March 25, 2020: FDA’s actions in response to coronavirus disease | 16 diagnostic tests authorized for emergency use (PDF, 95 KB)
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March 18, 2020: FDAs actions in response to coronavirus disease at home and abroad | MCMi annual program update (PDF, 277 KB)
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March 11, 2020: FDA’s actions in response to coronavirus disease at home and abroad (PDF, 286 KB)
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March 4, 2020: FDA’s actions in response to coronavirus disease at home and abroad (PDF, 119 KB)
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February 19, 2020: FDA’s actions in response to 2019 novel coronavirus at home and abroad (PDF, 120 KB)
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February 5, 2020: Novel coronavirus (2019-nCoV) updates from FDA (PDF, 125 KB)
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January 22, 2020: Funding deadline alert: Call for medical countermeasure regulatory science white papers (PDF, 72 KB)
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January 8, 2020: Register now for the training course Achieving Data Quality and Integrity in Maximum Containment Laboratories (PDF, 105 KB)
- December 19, 2019: Medical countermeasure news alert: First FDA-approved vaccine to prevent Ebola (PDF, 111 KB)
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December 18, 2019: Save the dates for 2020 training courses | FDA authorizes marketing of MRSA diagnostic (PDF, 158 KB)
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December 4, 2019: Human organ chips for radiation countermeasure development | New winter events (PDF, 95 KB)
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November 20, 2019: New Ebola and Marburg virus research | Final guidance for developing smallpox treatments (PDF, 121 KB)
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November 6, 2019: Ebola survivor study expanded | FDA clears 3rd Zika diagnostic test (PDF, 292 KB)
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October 23, 2019: Miss the FDA Science Forum or Scientific Computing Days? Recordings available | Learn about FDA's Cybercrime Investigations Unit (PDF, 182 KB)
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October 10, 2019: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens (PDF, 110 KB)
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September 25, 2019: FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox (PDF, 249 KB)
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September 11, 2019: FDA action makes blood product more accessible to U.S. military _ View the FDA Science Forum webcast live today (PDF, 139 KB)
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August 28, 2019: Learn how predictive toxicology can support drug development, including medical countermeasures - September 18 workshop (PDF, 112 KB)
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August 14, 2019: Register now for the FDA Science Forum | More September workshops (PDF, 122 KB)
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July 31, 2019: Research centers: partner with FDA to apply for new advanced manufacturing innovation funding | Mustard gas countermeasure cleared (PDF, 103 KB)
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July 17, 2019: How FDA uses science to speed medical device innovation (PDF, 141 KB)
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June 26, 2019: Translating new technologies into safe, effective medical countermeasures | New preparedness legislation (PDF, 92 KB)
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June 12, 2019: Got pathogens? (PDF, 75 KB)
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May 29, 2019: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies | Hurricane preparedness (PDF, 144 KB)
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May 8, 2019: Anthrax preparedness guidance for government public health and emergency response stakeholders | New FDA website (PDF, 152 KB)
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April 24, 2019: Join the National Biodefense Science Board | Emergency Use Authorization updates (PDF, 127 KB)
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April 10, 2019: 28 new medical countermeasures in 2018 (new report!) | April 17 Biodefense Summit (PDF, 176 KB)
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March 27, 2019: Medical countermeasure monitoring and assessment update | Advancing new TBI treatments and blood pathogen reduction technologies (PDF, 109 KB)
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March 13, 2019: Medical countermeasure funding deadline | FDA's critical role in ensuring supply of influenza vaccine (PDF, 179 KB)
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February 27, 2019: New clinical data quality course for high-consequence pathogens | Emergency diagnostics news (PDF, 215 KB)
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February 13, 2019: Ebola research update | 2019 funding deadline reminder (PDF, 129 KB)
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December 12, 2018: Innovating to protect the U.S. blood supply from emerging pathogens (PDF, 135 KB)
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November 28, 2018: FDA's role: How FDA helps make medical countermeasures available during public health emergencies (PDF, 107 KB)
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November 14, 2018: FDA authorizes emergency use of first Ebola fingerstick test with portable reader | FDA, DoD formalize collaboration (PDF, 173 KB)
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October 31, 2018: FDA approves new flu treatment | Medical device cyber security | Dried plasma guidance (PDF, 196 KB)
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October 17, 2018: Organs-on-chips research update | FDA and NASA sign agreement (PDF, 178 KB)
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September 26, 2018: DoD and FDA collaborate to help speed Ebola medical countermeasures | Do you have a plan for emergency medication? (PDF, 551 KB)
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September 14, 2018: FDA outlines plans to address antibiotic resistance | Update on medical countermeasure monitoring (PDF, 90 KB)
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August 30, 2018: A flexible clinical trial design for emerging disease outbreaks | Tropical disease priority review voucher additions (PDF, 127 KB)
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August 15, 2018: Regulatory science research tools | Join the challenge to identify biothreat pathogens (PDF, 107 KB)
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July 31, 2018: Advancing FDA's medical countermeasures mission | TPOXX Drug Trial Snapshot (PDF, 120 KB)
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July 13, 2018: Medical countermeasure news alert: FDA approves smallpox therapeutic and chemical nerve agent treatment (PDF, 86 KB)
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July 11, 2018: Revised Zika virus blood testing guidance | Emergency Use Authorization to support American military personnel (PDF, 127 KB)
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June 20, 2018: Zika virus research update | FDA statements on biopreparedness (PDF, 114 KB)
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June 6, 2018: New Medical Countermeasures Initiative report | Mitigating IV drug shortages (PDF, 147 KB)
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May 30, 2018: FDA's response efforts for Ebola virus outbreak in DRC | Guidance to assist in development of drugs to prevent anthrax (PDF, 231 KB)
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May 16, 2018: N95 regulation update | Expanding collaborations to improve BSL- 4 data quality | New food defense training (PDF, 212 KB)
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April 25, 2018: "What are MCMs?" infographic | FDA authorizes first test to identify emerging pathogen Candida auris (PDF, 288 KB)
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April 12, 2018: Ask us anything about biosimilars | New guidances on clinical research in pregnant and pediatric populations (PDF, 337 KB)
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March 29, 2018: FDA approves Leukine for Acute Radiation Syndrome | Blood supply model could help nation prepare for emergencies (PDF, 299 KB)
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March 14, 2018:FDA warns of fraudulent and unapproved flu products | BAA funding reminder | New events (PDF, 92 KB)
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February 28, 2018: Medical countermeasure funding opportunities | Quick concussion blood test | Rapid flu test facts (PDF, 192 KB)
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February 12, 2018: Ensuring a stable, secure supply of a critical radioactive imaging product | Advancing next-gen antibiotics | New events (PDF, 159 KB)
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January 31, 2018: Register now for data quality in BSL-4 labs course | Learn about biosimilars | Auto-injector EUA update (PDF, 182 KB)
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January 17, 2018: Material threat medical countermeasure priority review voucher guidance issued | FDA & DoD launch program (PDF, 106 KB)
- For 2017 MCMi newsletters, please visit this archive page
- For MCMi newsletters from 2014-2016, please visit this archive page