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Regulatory Compliance US Department of Health and Human Services FDA Licensing COVID-19 Vaccine Compliance Fraud Public Health Governance Medicare More Related Topics >
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

MAY 17, 2022

ANVISA’s RDC 665/2022 (link in Portuguese) replaces previous regulations, including RDC 16/2013 and IN 08/2013, and went into effect on 02 May 2022. ANVISA has issued a new resolution that updates Brazilian Good Manufacturing Practices (BGMP) for medical devices and in vitro diagnostic (IVD) products.

FDA 75
FDA Compliance Informed Consent Hospitals 75
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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. The G/N MDL was created in 2013 and mostly settled in 2016. Plaintiff’s complaints about “consent” related to the vaccination. The device labeling specifically mentioned it. The prescribing cosmetic surgeon knew about it. Preemption.

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