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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

It includes aspects such as home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs, and electronic informed consent. Decentralization is enabled by the advancement of digital tools, telemedicine, and more mobile and local healthcare.

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. The device labeling specifically mentioned it.

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Suing the Certifiers – A Dangerous Undertaking

Drug & Device Law

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. 2015 WL 6393869 (S.D.

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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . 2015 WL 4081909 (Pa. June 30, 2015): [T]he testimony was relevant. . . 71 (4th Cir.

Doctors 59