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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law

The government asserted additional allegations that are outside our scope. Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” Zarzamora Press Release. Complaint ¶ 55.

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Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v.

IT 52
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The Promise and Pitfalls of AI in Medicine: Guest Bob Wachter

GeriPal

We discuss, among other things: Findings that in several studies AI was rated by patients as more empathetic than human clinicians (not less, that isn’t a typo). The experience of both patients and clinicians isn’t very good. Bob recently wrote an essay in JAMA on AI and delivered a UCSF Grand Round s on the same topic.