US FDA Stuck With Less Flexibility On Drug Vs. Device Designations After Appeals Court Decision
Products that seem to meet both drug and device standards will probably now be designated devices after an appeals court concludes that US FDA has less discretion than it has historically exercised.
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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.