2001, FDA and World Health - Health Care Compliance Brief

SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

DECEMBER 16, 2022

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. United States Food and Drug Administration (FDA) – Regulations and guidance. The FDA is issuing this guidance to provide clarity and predictability for software manufacturers on this topic.

FDA

FDA Compliance COVID-19 Licensing

Zantac Chronicles – Concluding Chapters in the MDL

Drug & Device Law

DECEMBER 27, 2022

Filing a citizen’s petition, Valisure shocked the FDA into an ill-advised recall by reporting that “tests found NDMA in ranitidine in excess of 3,000,000 ng [nanograms] per pill” – far above FDA’s 96 ng/day “daily limit.” The FDA recognized these results as bogus, “conclud[ing] that. . . 2022 WL 17480906, at *1.

FDA

FDA World Health Governance

Health Care Compliance Brief

SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

Zantac Chronicles – Concluding Chapters in the MDL

Webinars

Stay Connected