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

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

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information and all current EUAs on our Emergency Use Authorization page, or view the EUA archive for EUAs that are no longer in effect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

FY 19 update! 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
  • January 16, 2019: From HHS - BARDA's DRIVe Ventures has posted an RFI (PDF, 298 KB) to survey the market for venture capital organizations that are capable of managing a sustainable portfolio of medical countermeasure products and technologies to address influenza, emerging infectious diseases and chemical, biological, radiological and nuclear (CBRN) threats. Respond by 5:00 p.m. ET, March 4, 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.
  • November 20, 2018: From NIH - The Centers for Medical Countermeasures against Radiation Consortium (CMCRC), funded by the National Institute of Allergy and Infectious Diseases (NIAID), are now accepting applications disclaimer icon for pilot projects focused on practical approaches for radiation biodosimetry or the development of agents for the mitigation of acute or late radiation effects. Apply by March 15, 2019.
  • August 1, 2018: From NIH - Spotlight on the Chemical Countermeasures Research Program Network and associated NIH funding opportunities
  • 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).
  • May 1, 2018: Slides are now available from FDA Sentinel Industry Day 2018 - also see FDA's Sentinel Initiative
  • 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: 02/22/2019
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