Emergency Preparedness and Response

MCMi News and Events

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News from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi), and federal and industry partners. This page is updated frequently.

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For more news and events by category, view the drop-down sections below.

For more news, visit our News Archive, or view previous MCMi newsletters

  • April 25-26, 2019: Disasters and Health: State of Science disclaimer icon (Washington, DC), hosted by the National Center for Disaster Medicine and Public Health, Uniformed Services University - The objective of the symposium is to identify the important issues enabling and constraining an evidence-based approach to disaster preparedness and response, with a particular focus on health.
  • April 29, 2019: Health Canada and U.S. FDA Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Human Use (ICH) (Silver Spring, MD and webcast) - The purpose of the public meeting is to solicit public input prior to the next ICH Assembly meeting and the expert working groups meetings in Amsterdam, Netherlands, scheduled for June 1 - 6, 2019.
  • May 1, 2019: FY 2019 Generic Drug Regulatory Science Initiatives public workshop (Silver Spring, MD and webcast) - To provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives.  To attend in-person or via webcast, register by April 1, 2019 by emailing complete contact information for each attendee (including the attendee's name, title, affiliation, address, email, and telephone number) to GDUFARegulatoryScience@fda.hhs.gov. Also submit any requests to make oral presentations as part of your registration email. Submit comments by June 1, 2019. (Federal Register notice)
  • May 2, 2019: Reagan-Udall Foundation annual public meeting disclaimer icon (Washington, DC)  - The Foundation will discuss its activities and how they support FDA. Register by 5:00 p.m. ET April 30, 2019. (Federal Register notice)
  • May 14, 2019: Public workshop: BioCompute Objects: Tools for Communicating NGS Data and Analysis (Silver Spring, MD and webcast), co-sponsored by FDA, the George Washington University and the BioCompute Partnership to engage more stakeholders in creating and using BioCompute for NGS and other bioinformatics data analysis communications with the FDA. Specifically, the workshop will have two components: use case examples, and hands on & demonstrations of new tools that leverage BioCompute. A new Precision FDA-BioCompute Challenge will also be launched at the event. Space limited; please register disclaimer icon in advance.
  • May 20-22, 2019: Filovirus Animal Non-clinical Group (FANG) Workshop disclaimer icon (Rockville, MD and webcast) - To update the FANG (an interagency working group) and other members of the filovirus community on cross-cutting topics that impact vaccine and therapeutic product development and regulatory approval. Due to security requirements, if you are not an American citizen, you must register at least 2 weeks before the event.
  • May 29-30, 2019: Regulatory Education for Industry (REdI) Annual Conference (Boston, MA and webcast) - This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements.
  • June 26-28, 2019: NIIMBL National Meeting disclaimer icon (Washington, DC) - The program will feature perspectives from industry and government leaders and showcase the work of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) community as it develops the cutting-edge technologies and training programs designed to enhance patient access to life-saving medicines. FDA's Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER), and Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), are two of the featured speakers on June 27. (fee)
  • July 12, 2019: Public meeting: Limited Population Pathway for Antibacterial and Antifungal Drugsdisclaimer icon (Silver Spring, MD and webcast). The purpose of the meeting is to provide a public forum for FDA to listen to comments on the draft guidance for industry, Limited Population Pathway for Antibacterial and Antifungal Drugs (PDF, 128 KB), that was published in the Federal Register on June 13, 2018. FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance. Register by July 1, 2019. Submit comments by August 12, 2019.
  • July 30-31, 2019: Radiation Injury Treatment Network (RITN) workshop disclaimer icon - Crisis in context: Minding the gaps in medical preparedness for a Rad/Nuke incident (Arlington, VA) (fee)
  • September 11-12, 2019: 2019 FDA Science Forum (Silver Spring, MD) - Save the date!
  • September 25-26, 2019: 2019 Complex Generic Drug Product Development Workshop  (College Park, MD and webcast) - FDA will link GDUFA science and research on complex products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science.
For more events, including recordings/presentations from previous events, visit our Events Archive
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer - also see Zika Virus Diagnostic Development and Zika Emergency Use Authorization information
  • April 18, 2019: EUA amendment - In response to Siemens Healthcare Diagnostic Inc.’s request, FDA concurred (PDF, 137 KB) with the request to modify the ADVIA Centaur Zika test to include surfactant in the ADVIA Centaur Zika IgM assay reagent buffers and the related updates of the Instructions for Use (PDF, 2.8 MB). For more information, see Emergency Use Authorizations (Devices)
  • April 2, 2019: EUA amendment - In response to Chembio Diagnostic Systems, Inc.'s request, FDA concurred (PDF, 88 KB) with modifications to the authorized Instructions for Use (PDF, 2 MB) for the DPP Ebola Antigen System to update 1) the cross-reactivity performance for Plasmodium malariae and Streptococcus pneumoniae in whole blood, and 2) the endogenous interference data for Rheumatoid Factor, Glucose, unconjugated bilirubin, cholesterol and HAMA.
  • January 30, 2019 and February 1, 2019: EUA amendments - In response to OraSure Technologies, Inc.’s request, FDA concurred with modifications to EUAs for the OraQuick Ebola Rapid Antigen Tests for use with whole blood and cadaveric oral fluid, respectively.  For more information, see Emergency Use Authorizations (Devices)
  • December 27, 2018: EUA amendment - FDA concurred (PDF, 66 KB) with modifications to the authorized Instructions for Use labeling for the LIAISON XL Zika Capture IgM assay, including DiaSorin Inc.'s request to modify the name from LIAISON XL Zika Capture IgM to LIAISON XL Zika Capture IgM II. Additional technical information, including revised instructions for use
  • November 9, 2018: FDA issued (PDF, 103 KB) an EUA for emergency use of Chembio Diagnostic Systems, Inc.’s DPP Ebola Antigen System for the presumptive detection of Ebola virus. This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. More information, including fact sheets - Also see: FDA authorizes emergency use of first Ebola fingerstick test with portable reader 
  • August 7, 2018: Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines - The HHS Secretary is amending the August 1, 2016 Declaration to extend the effective time period of the declaration through December 31, 2022 and to clarify and add to the list of covered countermeasures to include all Zika virus vaccine types and technologies. Also see PREP Act
  • August 3, 2018: EUA amendment - In response to Chembio Diagnostic Systems, Inc.'s request, FDA concurred (PDF, 129 KB) with the modifications to the authorized Instructions for Use labeling for the DPP Zika IgM Assay System to correct some typographical and formatting errors. Additional technical information, including revised instructions for use
  • July 31, 2018: Declaration Regarding Emergency Use of Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Correction - On July 9, 2018, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of freeze dried plasma (FDP) for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. This notice is correcting the July 16, 2018 notice to correctly state the Secretary's declaration. Also see French FDP EUA Information
  • July 9, 2018: FDA issued (PDF, 208 KB) an Emergency Use Authorization (EUA) to the U.S. Department of Defense (DoD) to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP) manufactured by the Centre de Transfusion Sanguine des Armées. Under the EUA, this product is authorized for the treatment of U.S. military personnel with severe or life-threatening hemorrhage due to traumatic injuries sustained in the conduct of military operations in situations when plasma is not available for use or when its use is not practical. More information, including fact sheets
  • May 3, 2018: FDA has posted new tables detailing performance characteristics of Zika virus diagnostic tests (assays) currently available for use under Emergency Use Authorization (EUA). The tables include information about analytical sensitivity, along with other performance characteristics determined during EUA evaluation. Table 1: Molecular ZIKV EUA Assays - Performance Characteristics (PDF, 200 KB); Table 2: Molecular ZIKV EUA Assays - Key Characteristics (PDF, 247 KB) - For more information, see Zika Virus Emergency Use Authorization
  • July 2017:  New resource: 21st Century Cures Act: MCM-Related Cures Provisions - the Cures Act includes MCM-specific provisions, including two FDA-specific MCM provisions: amending FDA’s EUA authority, and creating a material threat MCM priority review voucher program
  • January 2017: Guidance - Emergency Use Authorization of Medical Products and Related Authorities - This guidance finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces the following two guidance documents: Emergency Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions and Answers (April 2009). (Federal Register notice)
  • FDA issued a PAHPRA question and answer document (PDF, 762 KB) in 2014 to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies

View more information and all current EUAs on our Emergency Use Authorization page, or view the EUA archive for EUAs that are no longer in effect
 

View more MCM-related guidance information by topic on our Guidances and Other Information of Special Interest to MCM Sponsors page, or by date on our MCM-Related Guidance by Date page.  

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  • November 19, 2018: FDA is Advancing New Efforts to Address Drug Shortages - A key component of our public health mission is to help ensure Americans have access to safe and effective medicines. That’s why, as drug shortages arise, we take immediate action within our authorities, working across the FDA and with other government agencies, industry, and other stakeholders, to minimize the impact of these shortages and maintain or restore availability of critical medicines for the patients who need them.
  • September 20, 2018: FDA has released the latest edition of the (CDER) Director’s Corner Podcast - Dr. Woodcock discusses what FDA is doing to address drug shortages, and how FDA is working with industry to help lessen their impact (audio and transcript files available).
  • August 22, 2018: Expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles (PDF, 286 KB) – FDA issued a memo to government public health and emergency response stakeholders extending the expiration date of certain lots of doxycycline hyclate 100 mg capsules held in strategic stockpiles for anthrax emergency preparedness and response purposes.

  • March 23, 2018: Expiration dating extension update: FDA is alerting civilian health care professionals and emergency responders of additional AtroPen (atropine) lots that are no longer useable and should be properly disposed of. Please refer to the table on this page for such updates.
  • October 27, 2017: In September 2017, CDC’s Division of Strategic National Stockpile and FDA hosted a webinar to discuss FDA’s April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF, 226 KB). A recording of this webinar, slides and Q&A disclaimer icon (under Resources tab) are now available in CDC TRAIN (free account required).
  • Get the Drug Shortages 2 app for Android disclaimer icon or Apple disclaimer icon devices - opt in to receive notifications on your mobile device when FDA adds or updates shortage information about a drug product or one or more drugs within a selected therapeutic category

For a complete list of shortages, view our Drug Shortages or Vaccines, Blood and Biologic Shortages pages or search the Drug Shortages Database - also see: How to report a product shortage or supply issue to FDA 

FDA funding opportunity - In February 2018, FDA revised its Broad Agency Announcement (BAA) disclaimer icon for research and development to support regulatory science and innovation. MCM-related research submissions are encouraged under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health Security. The current BAA announcement will remain open until further notice, but proposers are encouraged to submit white papers by March 29, 2019 for current fiscal year awards. More about MCM-related extramural research
  • April 3, 2019: From NIH - Funding Opportunities for Emerging Infectious Diseases Research Centers - The network will conduct clinical and field studies of endemic zoonotic and vector-borne diseases that have the greatest potential to become pandemic threats, develop reagents for the broader research community, and during an outbreak mount a rapid and effective research response. Applications are due by 5:00 p.m. ET June 28, 2019.
  • April 1, 2019: FDA Announces Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals - FDA announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals. The agency also posted a list of the affected products. FDA's Center for Veterinary Medicine (CVM) will accept research applications for the fiscal year 2019 program from April 1 to June 3, 2019.
  • March 20, 2019: From NIH - NIAID is seeking proposals to carry out research in one of three areas: radiation countermeasures, therapeutics for antibiotic-resistant (AR) bacteria, and vaccine candidates for AR bacteria. Submit proposals by May 20, 2019.
  • March 6, 2019: From NIH - Opportunity for Funding of Radiation Medical Countermeasures Research - Optional letters of intent are due 30 days before the due date of May 31, 2019.
  • December 3, 2018: From NIH - Antimicrobial Resistance Diagnostic Challenge names five finalists - Selected entrants will receive $100,000 to further develop and test prototypes to improve detection of drug-resistant bacteria or differentiate between a bacterial and viral infection. Antibiotic resistant bacteria are a rising public health threat and cause at least 2 million infections and 23,000 deaths each year in the United States, according to CDC. Drug resistance can also erode the effectiveness of drugs provided as part of a medical response to bioterrorism, such as an anthrax attack. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and ASPR’s Biomedical Advanced Research and Development Authority (BARDA) are each contributing $10 million to the Challenge. The Challenge also was developed with technical and regulatory expertise from the CDC, FDA, and NIH Office of the Director.
  • June 5, 2018: HHS/ASPR unveiled DRIVe (Division of Research, Innovation, and Ventures), a new, transformative public-private engagement model designed to accelerate innovation and incentivize investors and innovators to tackle health security threats. Learn more about partnering opportunities, and view the DRIVe EZ-BAA (respond by May 31, 2019).
  • November 6, 2017: The HHS Office of Biomedical Advanced Research and Development Authority (BARDA) has issued a Broad Agency Announcement (BAA) seeking proposals for the advanced research and development of medical countermeasures (MCMs) for chemical, biological, radiological and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population. Respond by October 31, 2019.
 

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Page Last Updated: 04/19/2019
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