AIHC

OCTOBER 11, 2021

Written By: Compliance Blogger This article addresses COVID testing and consent considerations for: healthcare organizations, nursing homes and business associates or non-healthcare workplaces. Workplace-based testing should not be conducted without the employee’s informed consent.

COVID-19 52

COVID-19 Nursing Homes Informed Consent Nurses 52

SQA

MAY 17, 2022

China Regulatory Roundup: Latest Guidelines for Medical Device and IVD Compliance, 17 March 2022. For Investigator Sites, the subject areas are Organizational Aspects, Informed Consent of Trial Participants, Review of Trial Participant Data, and Management of Investigational Medicinal Product(s).

FDA 75

FDA Compliance Informed Consent Hospitals 75

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Negligence requires an evaluation of a defendant’s reasonableness, and all relevant NC authority includes relevant regulatory compliance in that mix. Plaintiffs’ own litigation strategy thus opened the door to compliance evidence.

FDA 105

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