Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER - Pink Sheet Citeline

US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.

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Amidst spreading infectious diseases and climate change, US FDA should renew its focus on neglected tropical diseases - PLoS One

In 2015, the United States Food and Drug Administration (US FDA) and other Department of Health and Human Services agencies helped respond to a public health emergency concerning Zika Virus during which 5,600 cases of the virus were reported in the United States mainland and 37,000 cases in Puerto Rico and other US Territories.

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