Hall Render
OCTOBER 5, 2023
Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.
SQA
APRIL 30, 2021
generic, biosimilar, or hybrid application), informed consent is irrelevant provided that both applications relate to a medicinal product with the same qualitative and quantitative composition in active substances and the same pharmaceutical form. European Medicines Agency (EMA) – Biologics.
Drug & Device Law
JANUARY 28, 2022
Fajardo held that Plaintiffs’ email was not in technical compliance with Connecticut rules of procedure and was especially critical of Plaintiffs for failing to cite any evidence in that email, which would have warranted a denial of their request. at *20 (citing Casey v. Toyota Motor Engineering & Mfg. 3d 322, 331 (5th Cir. at *13-*14.
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