MCMi News and Events
January 27, 2015: Update on Ebola clinical trial research - transcript from a media briefing on the status of clinical trials for Ebola vaccines and therapeutics from HHS officials
Save the date - April 27-May 1, 2015: FDA- sponsored course (a collaboration with UTMB): Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda, MD) - How to express interest in attending. (see Events below)
- For more news and events by category, view the drop-down sections below.
January 27, 2015: Update on Ebola clinical trial research - transcript from a media briefing on the status of clinical trials for Ebola vaccines and therapeutics from HHS officials including NIAID/NIH, CDC, BARDA and FDA
January 21, 2015: CDC has published a report from its 2013 Melioidosis Diagnostic Workshop.
January 21, 2015: FEMA is seeking nominations for its Youth Preparedness Council (applications due March 2, 2015), and its National Advisory Council , which advises the FEMA Administrator on all aspects of emergency management (applications due February 16, 2015).
January 15, 2015: CDC Ebola preparedness grant funding announcement - Hospital Preparedness Program (HPP) and Public Health Emergency Preparedness (PHEP) Cooperative Agreements/PHEP Supplemental for Ebola Preparedness and Response Activities - applications due February 20, 2015
January 14, 2015: FDA’s investigation into patients being injected with simulated IV fluids continues (also see Product shortages and availability below, and Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected)
- December 23, 2014: FDA authorized emergency use of the LightMix® Ebola Zaire rRT-PCR Test (also see Emergency Use Authorization below)
December 23, 2014: HHS blog - Back from fighting Ebola on the front lines
December 22, 2014: FDA approved Rapivab (peramivir) to treat influenza infection in adults. Rapivab is the first neuraminidase inhibitor approved for intravenous (IV) administration and is administered as a single IV dose. Other neuraminidase inhibitors approved by the FDA to treat influenza include oseltamivir, administered orally, and zanamivir, which is inhaled. Related, from the ASPR blog: BARDA-sponsored flu drug earns FDA approval
December 12, 2014: Public workshop: Immunology of Protection from Ebola Virus Infection - Webcast recording now available
December 8, 2014: The Presidential Commission for the Study of Bioethical Issues is requesting public comment on ethical considerations and implications of public health emergency response, with a focus on the current Ebola virus disease epidemic. Comments due February 6, 2015. Related: February 5-6, 2015 meeting agenda
- For more MCMi news, visit our News Archive page
- February 2-5, 2015: USDA Agricultural Research Service (ARS) 3rd International Biosafety & Biocontainment Symposium (Baltimore, MD)
February 5, 2015: 7th Annual Sentinel Initiative Public Workshop (Washington, DC) - Participants will discuss a variety of topics on active medical product surveillance, including an overview of the transition from the Mini-Sentinel pilot program to the full Sentinel System, and what that means for patients and other stakeholders. (Federal Register notice)
February 5-6, 2015: Presidential Commission for the Study of Bioethical Issues public meeting (Washington, DC and webcast) - The Commission will begin discussions about the ethical considerations and implications of public health emergency response with a focus on the current Ebola virus disease epidemic. FDA's Dr. Luciana Borio will co-present a session "Ethical Issues Associated with Research in the Context of a Public Health Emergency" - agenda - webcast (webcast link will be active during the meeting only) - (Federal Register notice)
February 9-11, 2015: ASM Biodefense and Emerging Diseases Research Meeting (Washington, DC)
February 18-20, 2015: 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 (registration is now open)
February 20, 2015: Public workshop - Optimizing FDA's Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests (Bethesda, MD and webcast) - register by February 12, 2015 to attend in person or via webcast; early registration is recommended as webcast connections are limited
March 4, 2015: Vaccines and Related Biological Products Advisory Committee meeting (Silver Spring, MD) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season.
April 13-15, 2015: National Foundation for Infectious Diseases 18th Annual Conference on Vaccine Research (Bethesda, MD)
April 14-17, 2015: 2015 Preparedness Summit – Global Health Security: Preparing a Nation for Emerging Threats (Atlanta, GA)
April 27-May 1, 2015: FDA-sponsored course (a collaboration with UTMB): Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda, MD) - There are no registration fees for the course, however, seats are limited and course attendees will be invited based upon diversity of roles, responsibilities and organization. How to express interest in attending. Express interest in registering by February 20, 2015.
May 4-6, 2015: 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
May 27-28, 2015: FDA Science Forum - Save the date! This year's FDA Science Forum will include medical countermeasure-related regulatory science topics.
May 27-29, 2015: 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
July 7-9, 2015: National Association of County and City Health Officials (NACCHO) annual conference (Kansas City, MO) - abstract deadline extended to January 4, 2015
August 10-12, 2015: 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 24-26, 2015: 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
For more events, including recordings/presentations from previous events, visit our Events Archive
December 23, 2014: FDA issued an EUA to authorize use of the LightMix® Ebola Zaire rRT-PCR Test for the presumptive detection of the Ebola Zaire virus in a preparation of whole blood from individuals with signs and symptoms of Ebola disease. The test runs only on specified instruments used by CLIA high complexity laboratories or similarly qualified non-U.S. laboratories. more
November 26, 2014: In response to altona Diagnostics GmbH’s request to amend this EUA, on November 26, 2014 FDA reissued (PDF, 263 KB) the November 10, 2014 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. more
November 10, 2014: (see note above about update on November 26, 2014) FDA authorized emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 to detect Ebola viruses. This EUA provides another commercial Ebola diagnostic (in addition to the October 25, 2014 EUA for the BioFire Defense FilmArray Biothreat-E test). Note: Documents issued on November 10, 2014 are now archived. more
October 25, 2014: FDA authorized emergency use of two BioFire Defense diagnostic tests to detect the Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection, or who are at risk for exposure, or may have been exposed (in conjunction with epidemiological risk factors). The EUA for the FilmArray Biothreat-E test enables hospitals with laboratories that fit these characteristics to conduct a PCR test for Ebola in-house, without having to send the sample to an outside lab. more
October 10, 2014: FDA authorized emergency use of two Centers for Disease Control and Prevention (CDC) diagnostic tests to detect the Ebola Zaire virus in individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. Use of these tests is limited to qualified laboratories designated by the CDC. more
October 10, 2014: Upon request from the U.S. Department of Defense (DoD), FDA has reissued the August 5, 2014 Emergency Use Authorization (EUA) for use of a DoD diagnostic test to detect the Ebola Zaire virus. The reissued EUA replaces the August 5, 2014 EUA. The EUA has been amended to expand the types of specimens that can be tested to include whole blood and plasma, in addition to blood or plasma that has been treated to make the sample non- infectious. more
August 5, 2014: (see note above about update on October 10, 2014) Emergency Use Authorization for DoD EZ1 Real-time RT-PCR Assay for the presumptive detection of Ebola Zaire virus - FDA has authorized the use of an in vitro diagnostic test developed by the U.S. Department of Defense (DoD) to detect the Ebola Zaire virus. The agency has authorized its use in laboratories designated by DoD to help facilitate effective response to the ongoing Ebola outbreak in West Africa. (Related: August 12, 2014 Federal Register notice - HHS Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola; September 17, 2014 Federal Register notice - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus)
June 10, 2014: Emergency Use Authorization (Potential Emergency) for CDC IVD for MERS-CoV - In response to CDC’s request to amend this EUA, on June 10, 2014 FDA reissued the June 5, 2013 EUA in its entirety with the CDC-requested amendments incorporated. more
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
- 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
January 23, 2015: Current Good Manufacturing Practice Requirements for Combination Products - more about combination products
December 2014: A new feature on the FDA website allows you to search for guidance documents for all topics.
December 31, 2014: Guidance for Industry - Drug Supply Chain Security Act (DSCSA) Implementation--Product Tracing Requirements (PDF, 56 KB) - This guidance provides information pertaining to statutory requirements that will take effect on January 1, 2015. More about the DSCSA. (Federal Register notice)
December 30, 2014: Radiation Biodosimetry Devices (Draft Guidance) (PDF, 379 KB) - 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. Comments due March 30, 2015. (Federal Register notice)
December 18, 2014: Proposed rule - Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products - FDA is proposing to amend prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed, to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs. Submit comments by March 18, 2015.
December 17, 2014: Guidance for Industry - Providing Regulatory Submissions in Electronic Format--Standardized Study Data (PDF, 124 KB) - CDER and CBER
December 17, 2014: Guidance for Industry - Providing Regulatory Submissions in Electronic Format--Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (PDF, 81 KB) - CDER and CBER
December 16, 2014: Are you ready for the Drug Supply Chain Security Act?
December 8, 2014: Draft Guidance for Industry - General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (PDF, 375 KB) - submit comments by February 9, 2015 (Federal Register notice)
November 24, 2014: FDA has developed Drug Trials Snapshots to provide information to the public about who participated in the clinical trials for new FDA-approved drugs. Drug Trials Snapshot is part of a pilot project to provide information about the sex, age, race and ethnicity of clinical participants for a small group of recently approved drugs. (Federal Register notice)
November 21, 2014: Clinical Trials Registration and Results Submission (Federal Register notice) - HHS is seeking input on a proposed rule to update how data that were collected and analyzed in accordance with a clinical trial's protocol are to be submitted to ClinicalTrials.gov. Read a news release and summary of changes from NIH. Comments are due by February 19, 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.
January 14, 2015: FDA’s investigation into patients being injected with simulated IV fluids continues - Clinicians and office staff are encouraged to take steps to ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products into patients. While Sodium Chloride 0.9% Injection (IV normal saline) has been in tight supply, FDA has been working with manufacturers to increase supply. FDA is not objecting to the temporary distribution of additional IV normal saline from approved alternate sources. (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
March 28, 2014: FDA further extends expiration dates of DuoDote auto-injector lots manufactured by Meridian Medical Technologies. Certain lots of DuoDote can be used for two years beyond the labeled expiration date.