Justin Coen

Justin Coen

Venable LLP

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DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Our Military Personnel

Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical...more

4/24/2023  /  Department of Defense (DOD) , Emergency Use Authorization (EUA) , Expedited FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Military End Use , Pharmaceutical Industry

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

3/28/2023  /  Clinical Laboratories , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Public Health Emergency
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