July 19, 2017 | FDA Medical Countermeasures Initiative Update
On December 13, 2016, the 21st Century Cures (Cures) Act (H.R. 34; PL: 114-255) was signed into law. Many provisions of the law that are intended to facilitate the development of medical products will facilitate development of medical countermeasures (MCMs).
In addition, the Cures Act included MCM-specific provisions, including two that are FDA-specific: amending FDA's Emergency Use Authorization (EUA) authority, and creating an MCM priority review voucher program.
- 21st Century Cures Act: MCM-Related Cures Provisions (new FDA page)
- FDA Cures Act main page (more general information)
- FDA Cures Act deliverables
- How FDA plans to help consumers capitalize on advances in science (blog post by FDA Commissioner Dr. Scott Gottlieb)
Expiration date extensions for certain auto-injectors
FDA is alerting civilian health care professionals and emergency responders of updated dates through which certain lots of AtroPen (atropine), CANA (diazepam), DuoDote, and pralidoxime chloride auto-injectors, manufactured by Meridian Medical Technologies, may be used beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.
This posting and FDA’s June 26, 2017, memorandum (PDF, 88 KB) replace FDA’s March 2, 2016, memorandum (PDF, 58 KB) and all previous FDA web postings notifying health care professionals and emergency responders of extensions of the labeled expiration dates of certain lots of auto-injectors.
- More information, including lot numbers of affected auto-injectors
- About expiration dating extension
- August 14-15, 2017: NIST-DHS Standards for Pathogen Detection for Biosurveillance and Clinical Applications Workshop (Gaithersburg, MD) - register(fee)
- August 29, 2017: Regulatory/Scientific Challenges and Benefits of Repurposing Licensed Products for a Radiation Indication workshop (Rockville, MD and webcast), hosted by NIH/NIAID
- NEW! September 8, 2017: Public workshop - Pediatric Trial Design and Modeling: Moving into the Next Decade (Silver Spring, MD and webcast) - register
- NEW! September 13, 2017: Public workshop - Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices (Silver Spring, MD and webcast) - To attend in person, register by 4:00 p.m. ET September 1, 2017.
- NEW! September 18-19, 2017: Public workshop - Advancing the Development of Pediatric Therapeutics (ADEPT): Application of “Big Data” to Pediatric Safety Studies (Silver Spring, MD and webcast) - register by August 15, 2017
In case you missed it
- FDA develops rapid and sensitive assay to assess antibody response to Ebola virus vaccine without using the virus - Scientists at FDA have developed an assay that assesses the ability of antibodies to neutralize Ebola virus, using a technique that does not require the use of Ebola virus itself and can be automated for rapid testing of large numbers of samples - also see Development of a micro-neutralization assay for ebolaviruses using a replication-competent vesicular stomatitis hybrid virus and a quantitative PCR readout in the journal Vaccine (July 7, 2017) - more Ebola response updates from FDA
- HHS announced its intent to establish the Tick-Borne Disease Working Group, and is seeking nominations from qualified individuals. Apply by August 16, 2017.
- From NIH - Malaria drug protects fetal mice from Zika virus, NIH-funded study finds- blocking a key placental defense may limit maternal-fetal transmission of the virus (July 10, 2017) and Experimental Zika virus vaccines restrict in utero virus transmission in mice - vaccine candidates protect against Zika-related congenital damage (July 13, 2017) - Zika response updates from FDA
- From HHS/ASPR - Four Great Ways for Local Public Health to Increase National Health Security (July 12, 2017)