May 31, 2017 | FDA Medical Countermeasures Initiative Update
Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies: A Stand Alone Workshop
June 6-7, 2017 | Washington, DC
The National Academies of Sciences, Engineering, and Medicine will host a workshop to:
- Discuss the roles and efforts of the federal government and relevant stakeholders who have an interest in building and maintaining a national medical countermeasure (MCM) monitoring and assessment capability for public health emergencies
- Discuss federal monitoring and assessment efforts and opportunities for future work in areas including electronic health record capabilities, big data, clinical networks, and operations for response
- Help inform the development of strategic MCM monitoring and assessment plans for public health emergencies
FDA Acting Assistant Commissioner for Counterterrorism Policy RADM Carmen T. Maher, MA, BSN, RN, RAC will be the keynote speaker.
All stakeholders with an interest in monitoring the safety and efficacy of MCMs are encouraged to participate.
- More about this workshop
- More on monitoring & assessment of MCMs coming soon to our website
The agenda includes updates on MCM-related research: Zika, Ebola, biomarkers, next-gen sequencing, and more.
Can't attend in person? View the webcast:
Zika diagnostic EUA amendment:
Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov
- June 18-22, 2017: Drug Information Association (DIA) 2017 (Chicago, IL) - FDA Acting Assistant Commissioner for Counterterrorism Policy RADM Carmen T. Maher, MA, BSN, RN, RAC will present on international collaboration in times of public health crisis (fee)
- June 20-21, 2017: Combating Antimicrobial Resistance: A One Health Approach to a Global Threat—A Workshop (Washington, DC and webcast), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division
- June 21-22, 2017: The Need to Accelerate Therapeutic Development — Must Randomized Controlled Trials Give Way? (New York, NY and webcast) Hosted by the NYU School of Medicine and the New York Academy of Sciences - FDA speakers include Dr. Janet Woodcock and Dr. Luciana Borio (free; registration required to attend in person)
- June 26-29, 2017: Third annual Biodefense World Summit (Alexandria, VA), hosted by the Knowledge Foundation - includes a keynote presentation: Rapid Surveillance of the Ebola Genome Sequence with Microarray Technology by Robert Duncan, PhD, FDA/CBER (agenda) (fee)
- July 10, 2017: Public workshop - Sentinel Training at FDA (Silver Spring, MD and webcast) - Early registration is recommended. Also see FDA's Sentinel Initiative
Information for industry
- From CDER Small Business and Industry Assistance - Companies filing master files have one extra year to comply with electronic submission requirements. The FDA has extended the deadline for filing master files and all documents submitted to existing master files, in the electronic Common Technical Data (eCTD) format from May 5, 2017 to May 5, 2018. The compliance date for electronically submitting new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) remains unchanged. Podcast (MP3, 5.3 MB) also available. (May 25, 2017)
- FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug products. (May 22, 2017)
- Reminder: Comments are due by June 26, 2017 on a draft guidance for government public health and emergency response stakeholders entitled Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF, 226 KB). This document provides guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the FD&C Act of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. (Federal Register notice) Also see Expiration Dating Extension
In case you missed it
- FDA is announcing an opportunity for public comment on the information collection requirements related to exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile (SNS). Submit comments by July 24, 2017.
- CDC has published online resources for parents of babies born with recognizable birth defects related to congenital Zika infection (PDF, 251 KB) and for parents of babies infected with Zika before birth but who appear healthy (PDF, 252 KB). These roadmaps are designed to help parents navigate the series of screenings and tests recommended during their baby’s first year of life and help ensure that they receive the care they need. Also see CDC's Zika virus website, and Zika response updates from FDA (May 24, 2017)
- From CDC/NIOSH - New toolkit provides resources for emergency responders who experience dermal exposures to chemicals - Also see DERMaL eToolkit (May 24, 2017)
- From NIH - Zika virus spread undetected for many months, NIH-supported study finds - Virus quickly spread in the Americas, then diverged into distinct genetic groups (May 24, 2017)