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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements. Teva distributed 1,565 vials nationwide from 04 December 2020 through 18 August 2021 to four of its wholesale customers under the label for Teva Pharmaceuticals USA, Inc.

FDA 75
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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. Plaintiff’s complaints about “consent” related to the vaccination.

FDA 105