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May 25, 20232 min read

USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints

Today (26 May 2023) the United States Food & Drug Administration released multiple guidances related to both drugs/biologics and medical...

Oct 23, 20221 min read

USFDA Guidance: Multiple Endpoints in Clinical Trials & Gene Therapy for Neurodegenerative Diseases

Earlier on 21 October 2022, the USFDA released two finalized guidances "Multiple Endpoints in Clinical Trials" and "Human Gene Therapy...