Merck Delayed Reporting Vioxx Mortality Risk in Alzheimer’s Patients – JAMA Article

Researchers say Merck did not provide a timely analysis of clinical trial data showing Vioxx increased risk of death in Alzheimer’s group.

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US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

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