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Focus on Regulation

Tag Archives: CBER

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement  Public Law 115-92, which was enacted in 2017.  The law gives the DoD new opportunities to advocate to FDA for expedited development,

Hot Topics at FDLI Enforcement, Litigation and Compliance Conference

Topics discussed at the recent Food & Drug Law Institute’s (FDLI) Enforcement, Litigation and Compliance Conference included FDA Center leaders’ enforcement priorities, interagency enforcement actions, the implications of increasing globalization, and the diversion of controlled substances.  Among the highlights: Joseph Rannazzisi, Deputy Assistant Administrator in DEA’s Office of Diversion Control, said due diligence is the