How is product assessment different during a public health emergency? | November events

Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency

Going Beyond the Last Mile: Proceedings of a Workshop

During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs)—including drugs, vaccines, and devices—may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. As part of the United States’ scientific and research preparedness enterprise, there is an imperative to go “beyond the last mile” of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs. To further the discussion on the need for a more robust national capability for monitoring and assessing MCMs during PHEs, the National Academies of Sciences, Engineering, and Medicine (NASEM) and FDA hosted a public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies, on June 6–7, 2017 in Washington, DC. Related information Proceedings of this workshop, from  NASEM Medical countermeasures monitoring and assessment, from FDA Image: Considerations for MCM monitoring and assessment include: operations for response, electronic health data, unstructured/big data, and clinical networks. View a Section 508-compliant version of this image as part of RADM Carmen T. Maher's presentation (PDF, 1.6 MB) at the June workshop. (Photo credits, from left: CDC,  FEMA, LLNL, NIAID)

Webinar materials  Extending Expiration Dates of Stockpiled Doxycycline: Overview of FDA Guidance In September 2017, CDC and FDA hosted a webinar to discuss FDA’s April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF, 226 KB). A recording of this webinar, slides and Q&A are now available in CDC TRAIN (under Resources tab, free account required).

EUA Updates EUA amendment: November 6, 2017: LIAISON XL Zika Capture IgM Assay (DiaSorin Incorporated) - more info Reminder: Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA atCDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer. Information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated July 24, 2017.

Events November 16, 2017: Public hearing - Devices Referencing Drugs (Silver Spring, MD and webcast) - This hearing will discuss a potential approach for premarket review of medical devices intended for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue or collaborate on the new use. FDA has outlined a potential approach for premarket review of proposed devices referencing drugs (DRDs) and invites public input on this potential approach during this hearing and through comments to the hearing docket. New! November 16, 2017: Public meeting of the Antimicrobial Drugs Advisory Committee (Silver Spring, MD) - The committee will discuss new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens. New! November 30 - December 1, 2017: Blood Products Advisory Committee Meeting (Silver Spring, MD and webcast) - committee members will meet in open session to discuss topics including strategies to reduce the risk of transfusion-transmitted Zika virus

Information for industry FDA is seeking comments on a proposed collection of information for Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic. Comment by January 2, 2018. FDA is requesting nominations for a nonvoting industry representative(s) to serve on the Pediatric Advisory Committee. FDA is also requesting that industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Pediatric Advisory Committee for the Office of the Commissioner notify FDA in writing. Nominations received by December 4, 2017 will be given first consideration. FDA is announcing an opportunity for public comment on the information collection in the guidance for industry Expedited Programs for Serious Conditions—Drugs and Biologics (PDF, 160 KB). Comment by January 8, 2018. The HHS Office of Biomedical Advanced Research and Development Authority (BARDA) has issued a Broad Agency Announcement (BAA) seeking proposals for the advanced research and development of medical countermeasures (MCMs) for chemical, biological, radiological and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases that threaten the U.S. civilian population. Respond by October 31, 2019. More: MCM-Related Guidance by Date

In case you missed it FDA In Brief: FDA analysis reinforces the important role of medical product manufacturing to Puerto Rico’s economic vitality and the island’s jobs recovery - also see economic analysis: Securing the Future for Puerto Rico: Restoring the Island's Robust Medical Product Manufacturing Sector (PDF, 1.3 MB) (November 6, 2017) FDA is actively working with drug manufacturers to address critical shortages of IV fluids aggravated by Hurricane Maria’s impact on Puerto Rican drug manufacturing facilities. (November 14, 2017) FDA Voice - FDA’s Role in Medical Device Cybersecurity, by Suzanne Schwartz, MD, MBA, FDA/CDRH - also see FDA Fact Sheet: The FDA's Role in Medical Device Cybersecurity (PDF, 174 KB) (October 31, 2017) FDA Voice - FDA Widens Scope of Navigator – Information Tool for Expanded Access - FDA is widening the scope of the new Expanded Access Navigator tool, a comprehensive online information resource maintained by the nonprofit Reagan-Udall Foundation to facilitate pre-approval access to drugs. Previously this tool was rolled out for drugs that treat cancer. It will now apply to drugs that treat orphan diseases. (November 2, 2017) FDA has launched an interactive research tool called Resistome Tracker. Resistome Tracker is one of the first publicly available tools to provide visually informative displays of antibiotic resistance genes in bacteria. It is designed mainly for public health officials, academics and researchers who are using new genomics technologies to track and treat infectious diseases. (November 14, 2017)

November 13-19 marks U.S. Antibiotic Awareness Week and World Antibiotic Awareness Week. CDC has released Be Antibiotics Aware: Smart Use, Best Care, a national educational effort to continue to combat antibiotic resistance and protect patients from unnecessary side effects.