miércoles, 19 de julio de 2017

How does the 21st Century Cures Act impact medical countermeasures?

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July 19, 2017 |  FDA Medical Countermeasures Initiative Update

The Cures Act has two FDA-specific MCM provisions

MCM-Related Cures Provisions

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.
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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.
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