martes, 13 de febrero de 2018

Ensuring a stable, secure supply of a critical radioactive imaging product | Advancing next-gen antibiotics | New events

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update
Image: Reactor pool at the High Flux Isotope Reactor (HFIR) at Oak Ridge National Laboratory. Primarily a research reactor, the HFIR is also used for production of medical isotopes. Credit: U.S. Department of Energy Flickr

FDA and NRC pave way for first domestic supply of the most commonly used medical isotope in diagnostic imaging
System will help save and improve lives of patients, reduce risk of drug shortages, and strengthen national security
FDA and the Nuclear Regulatory Commission (NRC) took steps to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases. On February 8, 2018, FDA approved the RadioGenix System, a unique system for producing Technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging.

From FDA Commissioner Scott Gottlieb, M.D:
"This new technology was the result of a broad collaboration across the federal government and industry, and has the potential to benefit many patients as well as restore the U.S. ability to domestically supply a critical medical diagnostic tool for the first time in 30 years.

The system we’ve approved today will not only help save and improve the lives of patients, but will reduce the risk of drug shortages and strengthen our national security by creating a U.S.-based manufacturing capacity that is less vulnerable to supply disruptions." Read the full statement
Related links: 

Image: Reactor pool at the High Flux Isotope Reactor (HFIR) at Oak Ridge National Laboratory. Primarily a research reactor, the HFIR is also used for production of medical isotopes. Credit: U.S. Department of Energy Flickr
FDA reports on progress advancing policies for developing next-generation antibiotics
HHS released a report to Congress on progress made in facilitating the development and approval of new antibacterial and antifungal drugs, implementing stewardship programs to ensure their judicious use and assessing the impact of the Generating Antibiotic Incentives Now (GAIN) provisions on promoting the pipeline of antibacterial and antifungal drugs.

Related links:
EUA updates
Emergency Use Authorization, with emergency sign
EUA amendment
  • February 6, 2018:  DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.) more info
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, 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
Information for industry
More: MCM-Related Guidance by Date
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