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Accelerated approval and accelerated withdrawal – will the new clinical trial guidance bring US closer to Europe?

Written by: Srishti Gupta, PhD; Senior Consultant Contact: sgupta@partners4access.com In March 2023, the Food and Drug Administration (FDA) published, a first of its kind, draft

April 18, 2023

Blogs

FDA stokes controversy with Alzheimer’s drug approval – what will it mean?

By Max Rex, Consultant Email: mrex@partners4access.com On Monday 7th June, the FDA approved aducanumab, the first new treatment for Alzheimer’s in 18 years. Aducanumab, manufactured

June 18, 2021

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FDA

Accelerated approval and accelerated withdrawal – will the new clinical trial guidance bring US closer to Europe?

FDA stokes controversy with Alzheimer’s drug approval – what will it mean?

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