FDA Breakthrough Troubles Emerge In Effort To Speed Development
Inspection schedules, diagnostic review and other issues have emerged as some of FDA’s breakthrough therapy designees wend their way closer to the review and approval stages, and FDA says more guidance will be needed.
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Longer application review time has been producing the improved communication sponsors expected, but modifications to the user fee program have yet to make inspections go smoother.
The agency needs more experience making the decisions before it lays out the evidence threshold for a breakthrough designation, CDER Director Janet Woodcock says.
Industry official says FDA is responsive to questions from sponsors, but should issue more written guidance to help sponsors make development decisions.