SQA

MAY 17, 2022

China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022. The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements. United States Food and Drug Administration (FDA) – Regulations and Guidances.

FDA 75

FDA Compliance Informed Consent Hospitals 75

Drug & Device Law

AUGUST 8, 2022

Anyway, this fraudulent “doctor” allegedly “touched them without informed consent” and caused them “emotional distress. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. has no power to enforce compliance”), aff’d , 405 F.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA 105

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