2017 Informed Consent Licensing Public Health 
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. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively. Tackling AMR is one of ICMRA’s strategic priorities.
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.
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