SQA

FEBRUARY 15, 2023

To add to these documents, a template for “Substantial modification of performance study under Regulation (EU) 2017/746” is also provided. It includes aspects such as home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs, and electronic informed consent.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Hrymoc was tried in late 2017. 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. And lost again on appeal in Cates.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

MAY 30, 2022

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. . . . Abbott Laboratories , 2017 WL 5903362, at *10 (S.D.

Doctors 59

Doctors Licensing Informed Consent Hospitals 59