Genus Triumphs Over FDA In Barium Sulfate Product Classification Suit
The decision limits US FDA discretion in determining how to regulate products that seem to meet both drug and device standards.
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In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the US FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.
The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.
The all-day event will include sessions on Medical Device Reports, recalls and Sec. 522 postmarket studies.