- View the MCMi Fiscal Year 2014 Program Update (web version) - printable PDF (1.3 MB)
- August 5, 2015: New England Journal of Medicine Perspective - Combating Emerging Threats — Accelerating the Availability of Medical Therapies
August 3, 2015: MCMi email update - New Emergency Use Authorizations - Ebola and MERS-CoV - subscribe
July 31, 2015: FDA issued an Emergency Use Authorization for the OraQuick® Ebola Rapid Antigen Test
July 17, 2015: FDA issued an Emergency Use Authorization for the RealStar® MERS-CoV RT-PCR Kit U.S.
For more news and events by category, view the drop-down sections below.
September 4, 2015: The Hope Multipliers (video, 14:24) - In late 2014, the U.S. Public Health Service Commissioned Corps was activated to respond to the Ebola epidemic in West Africa. Officers were pulled from many different agencies within HHS and other components of the U.S. government. Some of the deployed FDA officers share their experiences in this video.
August 27, 2015: NIH/NIAID research news - NIAID Researchers Advance Development of Universal Flu Vaccine
August 27, 2015: CDC has clarified its guidance regarding personal protective equipment (PPE) for healthcare personnel caring for suspected and confirmed Ebola patients in U.S. healthcare facilities: updated PPE guidance for confirmed Ebola patients - CDC’s PPE guidance for clinically stable persons under investigation for Ebola - CDC Ebola PPE FAQs
August 26, 2015: NIH has announced the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2015. The list (PDF, 322 KB) includes biodefense research priorities (see Table 5). All nominations of pediatric therapeutics for future consideration should be submitted to Dr. Perdita Taylor-Zapata at email@example.com.
August 21, 2015: CDC Grand Rounds - Getting Smart About Antibiotics
August 19, 2015: FDA and CDC release NARMS data - FDA is publishing online data on its collection of bacteria – Salmonella, Campylobacter, E. coli, and Enterococcus – that are found in the guts of animals and humans, collected over the past 19 years as part of the National Antimicrobial Resistance Monitoring System (NARMS). CDC has also announced a new interactive tool, NARMS Now: Human Data.
August 19, 2015: NIH/NIAID research news - NIH scientists and colleagues successfully test MERS vaccine in monkeys and camels
August 17, 2015: HHS ASPR posted a webinar recording - The Healthcare and Public Sector Webinar: Preparedness Grants Opportunities
August 17, 2015: Development of new anthrax vaccine underway with HHS support - Project is the latest in the quest to protect health quickly (post-exposure) in a bioterrorism attack
August 13, 2015: NIH/NIAID research news - NIH-Funded Study Establishes Genomic Data Set on Lassa Virus - Knowledge of Virus Supports Efforts to Develop Medical Countermeasures. The data set is publicly accessible at the National Center for Biotechnology Information's BioProject website under PRJNA254017.
August 11, 2015: FDA Voice - Frances Oldham Kelsey, Ph.D., M.D.: A Pioneer in Public Health and Protection of Patients
August 7, 2015: The NIH National Institute of Environmental Health Sciences (NIEHS) Worker Training Program invites applications for cooperative agreements to support the development and implementation of occupational safety and health and infection control training programs for workers who may be at risk during infectious disease outbreaks. Respond by October 21, 2015.
August 7, 2015: Final rule - HHS is establishing the Pandemic Influenza Countermeasures Injury Table as authorized by the Public Readiness and Emergency Preparedness Act (PREP Act). The pandemic influenza countermeasures are identified in Secretarial declarations relating to pandemic influenza, including influenza caused by the 2009 H1N1 pandemic influenza virus and other potential pandemic strains, such as H5N1 avian influenza. Also see Countermeasures Injury Compensation Program.
August 5, 2015: New England Journal of Medicine Perspective - Combating Emerging Threats — Accelerating the Availability of Medical Therapies , by FDA's Luciana Borio, MD, Edward Cox, MD, MPH, and HHS ASPR Nicole Lurie, MD, MSPH
August 4, 2015: FDA Safety Communication: Supplemental Measures to Enhance Duodenoscope Reprocessing
August 4, 2015: CDC modeling projects growth of drug-resistant infections and C. difficile - The latest CDC Vital Signs (PDF, 2.1 MB) includes mathematical modeling that projects increases in drug-resistant infections and Clostridium difficile without immediate, nationwide improvements in infection control and antibiotic prescribing. Also see Stop the Spread of Antibiotic Resistance (video, 3:23).
August 3, 2015: MCMi email update - New Emergency Use Authorizations - Ebola and MERS-CoV - subscribe to these updates
- July 24, 2015: Funding opportunity - NIH and CDC are soliciting proposals from small businesses to conduct research and development, including possible medical countermeasure-related research - respond by October 16, 2015
- July 16, 2015: CDC is proposing to add certain H5N1 influenza virus strains to the list of HHS select agents and toxins. Comment by September 14, 2015.
- For more MCMi news, visit our News Archive page
- September 11, 2015: Public workshop, hosted by FDA and M-CERSI - Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy (College Park, MD) - register by September 1, 2015 (fee)
September 15, 2015: Vaccines and Related Biological Products Advisory Committee meeting (Silver Spring, MD and webcast) - the committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis. (Federal Register notice)
September 15, 2015: The Science Board to the FDA will meet via webcast to discuss a report from the Science Looking Forward subcommittee
September 16, 2015: (rescheduled) The DoD Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) will host an Industry Day regarding candidate technologies for the Joint CBRNE Advanced Capability Sets (JCACS) Advanced Technology Demonstration (ATD). (FedBizOpps RFI - respond by August 17, 2015)
September 17, 2015: ICAAC/ISID Joint Symposium: Emerging Infectious Diseases in the Time of Ebola (San Diego, CA), hosted by the International Society for Infectious Diseases (ISID), in collaboration with the American Society for Microbiology (ASM). This symposium is part of the ASM Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) September 17-21, 2015.
- September 18, 2015: 2015 FDA Science Writers Symposium - a special event intended to engage and inform science and health journalists about how the FDA is applying scientific approaches to critical public health issues - registration is free and open to credentialed media - register by September 14, 2015
- September 28-30, 2015: 2015 Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference - Mission Possible: Patient-Focused Manufacturing, Quality and Regulatory Solutions (Washington, DC)
- September 28, 2015: FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data (Silver Spring, MD and webcast) - The purpose of the workshop is to receive and discuss input from stakeholders regarding proposed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records. Register by September 18, 2015.
- September 29, 2015: CDC Public Health Grand Rounds - Shifts in Global Health Security: Lessons from Ebola
September 29-30, 2015: Public workshop - Medical Device Patient Labeling (Silver Spring, MD and webcast) - register to attend in person or online by September 21, 2015, 4:00 p.m. ET
September 30, 2015: America's PrepareAthon National Day of Action
September 30, 2015: Public meeting - Collecting On-Farm Antimicrobial Use and Resistance Data (Washington, DC) - register by September 18, 2015 (Federal Register notice)
October 5-6, 2015: Public meeting - Risk Evaluation and Mitigation Strategies (REMS): Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access (Federal Register notice) - when available, registration information will be located here - read more about REMS
October 14-16, 2015: BARDA Industry Day (Washington, DC)
October 16, 2015: Public workshop - Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use (Silver Spring, MD and webcast) - The purpose of this workshop is to receive input from stakeholders and discuss approaches to establish the performance of non-microbial biomarker assays for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. Register by October 6, 2015.
October 23, 2015: FDA Acting Chief Scientist Dr. Luciana Borio will present Ebola and the "new normal" at TEDxUSU (Logan, UT)
November 4-5, 2015: FDA Clinical Trial Requirements Regulations, Compliance and GCP Conference (Boston, MA), hosted by the Society of Clinical Research Associates
November 17-18, 2015: Association of Healthcare Emergency Preparedness Professionals (AHEPP) 1st Annual Conference (Omaha, NE) - A new professional association dedicated to advancing the field of disaster preparedness and response, AHEPP, is accepting members and announces their first national conference.
November 19, 2015: Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program (public webcast) - register by October 23, 2015.
February 8-10, 2015: ASM Biodefense and Emerging Diseases Research Meeting (Arlington, VA) - abstract submission opens September 8, 2015
For more events, including recordings/presentations from previous events, visit our Events Archive
July 31, 2015: FDA issued an EUA for the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, in laboratories or facilities adequately equipped, trained, and capable of such testing.This point of care test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. more
July 17, 2015: FDA issued an EUA to authorize the emergency use of the RealStar® MERS-CoV RT-PCR Kit U.S. for the in vitro qualitative detection of RNA from the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). more
May 12, 2015: FDA issued an EUA for the CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) for the in vitro qualitative detection of RNA from the Enterovirus D68 (EV-D68) strains detected in North America in 2014. This device will be distributed by CDC to qualified laboratories designated by CDC. more
April 22, 2015: The HHS Secretary issued a PREP Act declaration, effective February 27, 2015, to provide liability protection for activities related to Ebola virus disease therapeutics consistent with the terms of the declaration. (Federal Register notice - about the PREP Act)
March 23, 2015: FDA issued an EUA to authorize emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus.The test should be performed in CLIA moderate and high complexity laboratories, or similarly qualified non-U.S. laboratories, by personnel who have received specific training on the use of the Xpert® Ebola Assay on GeneXpert Instrument Systems. more
March 16, 2015: At the request of the manufacturer, FDA reissued the ReEBOV™ Antigen Rapid Test Emergency Use Authorization, first issued February 24, 2015, to allow distribution by certain authorized distributors. The Instructions for Use (PDF, 474 KB) have also been updated to incorporate these amendments. more
March 2, 2015: In response to CDC’s request, FDA reissued the two October 10, 2014 CDC EUAs in their entirety. The amendments authorize use of the CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument. The Instructions for Use and Fact Sheets for Health Care Providers have also been updated to incorporate these amendments (updated attachments). The amendments also allow the future use of “other authorized instruments,” of “other extraction methods” and of “other authorized specimen types” when requested by CDC and concurred with by FDA. more
March 2, 2015: In response to BioFire Defense, LLC’s request, FDA reissued (PDF, 326 KB) the October 25, 2014 FilmArray NGDS BT-E Assay EUA in its entirety. The amendments authorize use of plasma and serum specimens with the FilmArray NGDS BT-E Assay in addition to whole blood. The Instructions for Use (PDF, 740 KB) and Fact Sheet for Healthcare Providers (PDF, 40 KB) have also been updated to incorporate this amendment. The amendments also allow the future use of “other specimen types” when requested by BioFire Defense and concurred with by FDA. more
February 27, 2015: Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 - On February 6, 2015, the HHS Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad that involves enterovirus D68 (EV-D68). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68.
January 2, 2014: FDA issued a PAHPRA question and answer document (PDF, 762 KB) 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
- August 28, 2015: Draft Guidance for Industry - Nonproprietary Naming of Biological Products (PDF, 111 KB, Federal Register notice) and proposed rule: Designation of Official Names and Proper Names for Certain Biological Products - submit comments on the draft guidance by October 27, 2015 and the proposed rule by November 12, 2015. Related links: FDA Biosimilars page - FDA Voice: Naming and Biological Products
- August 18, 2015: Guidance for Industry - Providing Submissions in Electronic Format--Postmarketing Safety Reports for Vaccines (PDF, 77 KB) (Federal Register notice)
- August 17, 2015: Draft guidance - Rare Diseases: Common Issues in Drug Development (PDF, 306 KB) - comment by October 16, 2015 (Federal Register notice)
July 28, 2015: Draft Guidance for Industry - Request for Quality Metrics (PDF, 250 KB) and August 24, 2015 Quality Metrics Public Meeting - The public meeting and draft guidance are intended to gain stakeholders’ perspective in various aspects of the development and planned implementation of a quality metrics program launched under the authority of section 704 of the Food, Drug, and Cosmetic Act (FD&C Act). The guidance includes an explanation of CDER and CBER approaches to collecting and using data to aid in ensuring that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science and that they support continuous improvement and innovation in the pharmaceutical manufacturing industry. Register by August 7, 2015. Read an FDA Voice blog post about Quality Metrics. Submit comments on the draft guidance by November 27, 2015 (date extended). (Federal Register notice, correction of docket number)
July 27, 2015: Guidance for Industry - Analytical Procedures and Methods Validation for Drugs and Biologics (PDF, 134 KB) (Federal Register notice)
July 9, 2015: Final Guidance - Meetings with the Office of Orphan Products Development (PDF, 94 KB) - This guidance provides recommendations to industry, researchers, patient groups, and other stakeholders interested in requesting a meeting with FDA's Office of Orphan Products Development (OOPD) on issues related to orphan drug designation requests, humanitarian use device (HUD) designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related topics of concern. (Federal Register notice)
July 6, 2015: Drug Supply Chain Security Act (DCSA) Implementation: Product Tracing Requirements for Dispensers—Compliance Policy (PDF, 58 KB)
June 26, 2015: Draft Guidance - Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings (PDF, 355 KB) - comment by August 31, 2015 (Federal Register notice) - read more about medical gowns
June 16, 2015: FDA has a new Risk Evaluation and Mitigation Strategies site, a centralized, user-friendly source for approved REMS
June 11, 2015: Final Guidance for Industry - Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products (PDF, 313 KB) (Federal Register notice)
- May 28, 2015: FDA is extending the comment period for the Radiation Biodosimetry Devices (Draft Guidance) (PDF, 379 KB) published in the Federal Register of December 30, 2014. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. Comments are now due June 29, 2015. FDA has developed this draft guidance to facilitate study designs to establish the analytical and clinical performance characteristics of radiation biodosimetry medical countermeasure devices. Radiation biodosimetry countermeasure devices are devices used for the purpose of reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical or biological markers of exposure found in humans.
- May 27, 2015: FDA is delaying the compliance date for the final rule for the electronic submission of postmarketing safety reports for human drugs and biological products that published in the Federal Register of June 10, 2014. The compliance date for the final rule published at 79 FR 33072 is delayed until September 8, 2015.
- 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.
- August 11, 2015: The Drug Shortages 2 app is now available for Android devices on Google Play. Drug Shortages 2 includes an Alerts feature. You can 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. First launched March 4, 2015, the app identifies current drug shortages, resolved shortages and discontinuations of drug products. FDA is currently working on notifications for the iOS version of the mobile app. The app for Apple devices is available for free download via iTunes.
- July 8, 2015: FDA is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products—including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application—to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.
- April 2015: FDA has posted a new drug shortages infographic
- March 27, 2015: FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies - more about expiration dating extensions
- For a complete list of drug shortages, view our Drug Shortages page or search the Drug Shortages Database