article thumbnail

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. Regulatory authorities across China will use the Points as a basis to determine whether enterprises comply with GMP. The products are private labeled for Major Pharmaceuticals.

FDA 75
article thumbnail

Health Provider News – February 10, 2023

Hall Render

Dunleavy proposes extending Medicaid coverage for new mothers ARIZONA Banner Health pays $1.25M penalty over HIPAA failures from 2016 breach Arizona nursing school at risk of losing accreditation St. billion since pandemic U.S. billion since pandemic U.S. million to UMass Memorial Health Care for COVID-19 costs Four Mass.

article thumbnail

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. The G/N MDL was created in 2013 and mostly settled in 2016. In Cates the plaintiff encountered an unusual – so unusual as to be called “paradoxical” − but known, adverse reaction. The device labeling specifically mentioned it.

FDA 105