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Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the FDA’s most controversial drug approval decisions, from Addyi to Zohydro.

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With action imminent on Biogen’s Alzheimer’s drug aducanumab, the Pink Sheet looks back at 10 of FDA’s most controversial drug approval decisions, from Addyi to Zohydro.

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Responding To Rx Drug Promo Violations: Tips From OPDP

US FDA's staff have sometimes worked late into the night to help sponsors meet deadlines and avoid errors in responding to a notice of violation. As is often the case, early communication helps avoid problems.

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