Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application
Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.
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US FDA rescinds breakthrough designations for Tonix’ PTSD therapy Tonyma and Trevena’s novel pain drug Olinvo after clinical trial disappointments – and after identifying other regulatory pathways to market.
Listing of all ‘breakthrough’ drugs, including status and basis of designation. Updated weekly.
Success of enhanced communications in particular made one stakeholder wonder whether FDA could use it with non-breakthrough applications.