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SQA Regulatory Surveillance Summary | Monthly Update 2022 – Spring

SQA

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
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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. 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