TB Regimen Could Pave Way For More FDA Involvement In Neglected Tropical Diseases
TB Alliance plans to seek FDA approval for its treatment regimen, which is beginning a Phase IIb trial, as the agency looks to respond to calls for a clearer and quicker pathway for NTD drugs.
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Created by Congress to help FDA modernize medical product development and evaluation, the foundation will receive its first influx of federal money to support overhead in fiscal 2012.
In a recent report, the nonprofit BIO Ventures for Global Health shines a light on the NTD pipelines of Big Pharma, biotechs and others.
The agency’s infrastructure is not attracting many of the Product Development Partnership sponsors, Aeras official says, but new draft guidance could help.