MCMi News and Events
May 27-28, 2015: FDA Science Forum (Silver Spring, MD and webcast) - This year's FDA Science Forum will include medical countermeasure-related regulatory science topics. The focus of this year's Forum will be FDA's eight regulatory science priority areas - agenda (PDF, 214 KB)
May 12, 2015: FDA issued an Emergency Use Authorization for the CDC Enterovirus D68 2014 Real-time RT-PCR Assay
- May 8, 2015: FDA Medical Countermeasures Initiative update - Plague treatment approval + May 12 Ebola vaccine briefing doc - subscribe to these updates
April 17, 2015: FDA approves radiation medical countermeasure - FDA approves Neupogen® for treatment of patients with radiation-induced myelosuppression following a radiological/nuclear incident
For more news and events by category, view the drop-down sections below.
- May 21, 2015: World Health Assembly: Health Threats Don’t Recognize Borders - blog post by HHS Secretary Sylvia Mathews Burwell
- May 12, 2015: The FDA Vaccines and Related Biological Products Advisory Committee met in open session to discuss the development and licensure of Ebola vaccines (Silver Spring, MD and webcast) (Federal Register notice) - Agenda (PDF, 52 KB) - Briefing Document: Licensure of Ebola Vaccines: Demonstration of Effectiveness (PDF, 146 KB) - additional meeting materials will be posted here when available
May 11, 2015: Accurate and simultaneous identification of influenza viruses - FDA scientists showed that a "one-test-fits-all” technique they developed can simultaneously detect different influenza viruses in a single sample and determine their genetic makeup
May 11, 2015: FDA is requesting nominations for the Vaccines and Related Biological Products Advisory Committee - submit by June 10, 2015 (Federal Register notice)
May 8, 2015: Recent developments in combating antibiotic resistance: FDA's role - speech by Acting Commissioner Stephen Ostroff, MD at the ASM Conference on Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens, Washington, DC
May 8, 2015: FDA Medical Countermeasures Initiative update - Plague treatment approval + May 12 Ebola vaccine briefing doc - subscribe to these updates
May 6, 2015: “Today I am Healed. Tomorrow I Return to Heal Another” - blog post by U.S.Surgeon General Vice Admiral Vivek H. Murthy on his recent trip to Liberia with the U.S. Public Health Service
April 27, 2015: FDA is accepting applications for the Food Emergency Response Network (FERN ) Cooperative Agreement Program for Microbiological, Chemical, or Radiological laboratories. Apply by June 29, 2015.
April 23, 2015: The National Library of Medicine announced a funding opportunity for small projects to improve access to disaster medicine and public health information for health care professionals, first responders and others that play a role in health-related disaster preparedness, response and recovery. Proposals due July 6, 2015.
April 21, 2015: RFI - Innovations in Medical Countermeasure Continuous Manufacturing (FedBizOpps) - responses due by May 20, 2015
- For more MCMi news, visit our News Archive page
May 27-28, 2015: FDA Science Forum (Silver Spring, MD and webcast) - This year's FDA Science Forum will include medical countermeasure-related regulatory science topics. The focus of this year's Forum will be FDA's eight regulatory science priority areas - agenda (PDF, 214 KB) - register by May 15, 2015 (registration required)
May 27-29, 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
June 1-3, 2015: ISPE/FDA/PQRI Quality Manufacturing Conference (Washington, DC) - hosted by the International Society for Pharmaceutical Engineering, the Product Quality Research Institute, and FDA (Federal Register notice)
June 2-4, 2015: 13th Annual Vaccines & Therapeutics - Biodefense, Antimicrobial Resistance, Emerging Infectious Diseases (Washington, DC), hosted by Infocast, Inc.
June 5, 2015: GDUFA FY 2015 Regulatory Science Initiatives Part 15 public meeting (Silver Spring, MD and webcast) - current status of regulatory science initiatives for generic drugs and opportunity for public input - register by May 15, 2015
June 14-18, 2015: DIA 2015 51st Annual Meeting (Washington, DC) - FDA's Dr. Luciana Borio will discuss FDA's point of view in the forum New Pandemics: Lessons Learned from the Ebola Experience
June 20-24, 2015: In Motion: Science Transforming Policy in Food, Drug, and Medical Device Regulation (Indianapolis, IN), hosted by the Association of Food and Drug Officials - register by May 20, 2015
June 22-26, 2015: Biodefense World Summit (Bethesda, MD), including tracks on biodetection technologies (pathogen and biothreat detection, and point-of-care for biodefense) and biosurveillance integration - hosted by the Knowledge Foundation
July 7-9, 2015: National Association of County and City Health Officials (NACCHO) annual conference (Kansas City, MO)
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 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)
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.
For more events, including recordings/presentations from previous events, visit our Events Archive
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
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) - comment by July 14, 2015 (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)
March 11, 2015: Draft Guidance for Industry - Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (PDF, 336 KB) - comment by June 9, 2015 (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.
- 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 18, 2015: Comments on the CDRH Emergency Shortages Data Collection System are requested by May 18, 2015.
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)
November 24, 2014: View slides and listen to the recording of an FDA Basics webinar on drug shortages
October 16, 2014: FDA updates on saline drug shortage - In response to the ongoing shortage of 0.9% sodium chloride injection (normal saline), B. Braun Medical Inc. of Bethlehem, Pa., will temporarily distribute normal saline in the United States from its manufacturing facility in Germany. FDA is temporarily exercising its discretion regarding the distribution of B. Braun’s saline product from Germany, in addition to Baxter’s saline product from Spain and Fresenius Kabi’s saline product from Norway, to help address this critical shortage, which poses a serious threat to patients. more
September 24, 2014: The FDA Drug Shortage Assistance Award … Recognizing manufacturers who help prevent or alleviate drug shortages - blog post by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research; view award letters
- For a complete list of drug shortages, view our Drug Shortages page or search the Drug Shortages Database