Life Science Compliance Update - May Issue
This definitely is not a slow compliance year and here at the Update, we’ve been busy sifting through all the activities. This month we are featuring an exclusive – coverage of Greg Demske’s recent talk at Mitchell Hamline’s Health Law Institute Symposium. We have heard many OIG presentations over the years, but this one was decidedly different.
Carrying on with enforcement, Nicodemo Fiorentino has examined the recent Federal indictment of five, prominent New York physicians and found the connection between the allegations and what was reported in Open Payments. We also have taken a look at the recent Theranos settlement and the SEC noting that even private companies with no marketed products need to be careful with their public statements.
Shifting gears to the FDA, we have two articles covering the new guidance on health information collected by medical devices and the new draft guidance for compounding pharmacies.
Finally, we finish up with an update on Allergan’s apparently discredited strategy of using Native American tribes to expand patent protection.
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