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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...

Sharan Murugan
May 25, 20232 min read
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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...

Sharan Murugan
Oct 23, 20221 min read
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