Blame The Science, Not Regulation, For Targeted Therapy Shortfalls – FDA
In a report both boastful and defensive in tone, the agency explains why some disease areas are rife with targeted therapies while others have few or none.
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Is it a problem that new drugs clear some review divisions faster than others? FDA analysis attributes differences to the proportion of applications qualifying for expedited review – a natural outgrowth of the priority placed on medical advances – not a management problem in need of a fix.
In an interview with “The Pink Sheet,” new deputy commissioner for medical products says FDA needs better ways of helping stakeholders, public understand agency thinking.
It’s a question FDA has heard on Capitol Hill throughout the 21st Century Cures process: Why can’t all drug review divisions keep pace with the approvals seen in the oncology office – and shouldn’t steps be taken to ease development pathways for “lagging” conditions like Alzheimer’s and rare diseases? In the face of a tougher “Cures” debate in the Senate, FDA issues a white paper to more fully outline its response.