July 17, 2015: FDA issued an Emergency Use Authorization for the RealStar® MERS-CoV RT-PCR Kit U.S.
- June 30, 2015: View the MCMi Fiscal Year 2014 Program Update (web version) - printable PDF (1.3 MB)
For more news and events by category, view the drop-down sections below.
- July 24, 2015: FDA voice blog - Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs
- July 21, 2015: FDA Voice video blog - FDA Science Forum 2015: Views of FDA
- July 21, 2015: NIH/NIAID research news - Virus-Like Particle Vaccine Protects Mice from Many Flu Strains
- July 20, 2015: HHS partnership advances experimental Ebola drug - Department calls on Centers for Innovation in Advanced Development and Manufacturing
- July 17, 2015: New exercises released - The Food Related Emergency Exercise Bundle (FREE-B), a compilation of scenarios based on both intentional and unintentional food contamination events, designed with to assist government regulatory and public health agencies in assessing existing food emergency response plans, protocols and procedures
- 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.
- July 16, 2015: Innovation at FDA - These updated web pages outline how FDA is helping to speed treatments and cures to patients. The new section includes news, blog posts, speeches, fact sheets, and reports.
- July 15, 2015: HHS has published a Response and Recovery Resources Compendium, a comprehensive web-based repository of HHS resources and capabilities available to Federal, State, local, territorial and tribal stakeholders before, during, and after public health and medical incidents.
- July 14, 2015: Funding opportunity - NIAID is seeking development of therapeutic products for use in post-event settings following the release of a NIAID Category A, B, or C Priority Pathogen, or in response to naturally occurring outbreaks of infectious diseases caused by these pathogens. Responses are due August 31, 2015.
- July 9, 2015: CDC report - The Road to Zero: CDC's Response to the West African Ebola Epidemic, 2014-2015
- July 6, 2015: HHS awards improve health care, public health preparedness - Health departments across the country will receive more than $840 million in cooperative agreements from the U.S. Department of Health and Human Services to improve and sustain emergency preparedness of state and local public health and health care systems.
- July 1, 2015: HHS launches National Ebola Training and Education Center - three hospitals funded to train, prepare other U.S. health care facilities for Ebola and emerging threats
- July 2015: FDA white paper - Targeted Drug Development: Why Are Many Diseases Lagging Behind?
- July 1, 2015: FDA Medical Countermeasures Initiative update - MCMi annual program update: CRBN, Ebola, research + more - subscribe to these updates
- June 30, 2015: View the MCMi Fiscal Year 2014 Program Update (web version) - printable PDF (1.3 MB)
- June 30, 2015: View presentations and recordings from FDA's Office of Regulatory Science and Innovation Science Symposium, held April 27, 2015, and the 2015 FDA Science Forum, held May 27-28, 2015
- For more MCMi news, visit our News Archive page
- July 29, 2015: Science Board to the FDA meeting (Silver Spring, MD and webcast)
August 10-11, 2015: HHS Hurricane Sandy Conference: Translating Research into Practice (New York, NY)
August 10-12, 2015: FEMA SNS Preparedness course - A 3-day course on the Strategic National Stockpile for public health officials on how to design and execute MCM mass distribution and dispensing operations
August 10-14, 2015: Northwest Tribal Emergency Management Council - 2nd Annual National Tribal Emergency Management Conference (Spokane, WA) - registration open
August 24-26, 2015: FEMA MADT course - A 3-day course designed to prepare state and local public health staff to implement mass dispensing training for their agencies or jurisdictions
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 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 28-30, 2015: 2015 Parenteral Drug Association (PDA)/FDA Joint Regulatory Conference - Mission Possible: Patient-Focused Manufacturing, Quality and Regulatory Solutions (Washington, DC)
- September 29, 2015: CDC Public Health Grand Rounds - Global Health Security
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
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 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.
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.
For more events, including recordings/presentations from previous events, visit our Events Archive
July 17, 2015: FDA issued an Emergency Use Authorization (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
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.
May 22, 2015: Final Rule - Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - To better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture.
May 18, 2015: Draft Guidance for Industry and FDA Staff - Adaptive Designs for Medical Device Clinical Studies (PDF, 563 KB) - comment by August 17, 2015 (Federal Register notice)
May 15, 2015: Draft Guidance - Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (PDF, 431 KB) (Federal Register notice)
May 6, 2015: Draft Guidance - Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices (PDF, 1.4 MB)
April 2015: Biosimilars Guidances
April 13, 2015: Guidance for Industry - Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval (PDF, 500 KB)
April 13, 2015: Guidance for Industry - Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (PDF, 683 KB)
April 6, 2015: Guidance for Industry - Risk Evaluation and Mitigation Strategies Modifications and Revisions (PDF, 635 KB) - This guidance provides information on how FDA will define and process submissions for modifications and revisions to risk evaluation and mitigation strategies (REMS), as well as information on what types of changes to approved REMS will be considered modifications of the REMS and what types of changes will be considered revisions of the REMS. (Federal Register notice)
- December 2014: A new feature on the FDA website allows you to search for guidance documents for all topics.
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.
- 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
- March 4, 2015: FDA launches drug shortages mobile app - news release - app for Apple devices - app for Android devices
January 30, 2015: FDA’s investigation into patients being injected with simulated IV fluids continues - FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate multiple instances of simulated saline solution being administered to patients and to alert health care providers and regulatory officials throughout the country to raise awareness of the potential risk. (See also: Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected)
- For a complete list of drug shortages, view our Drug Shortages page or search the Drug Shortages Database