Breakthrough drugs for the interface between psychiatry and neurology

@article{Citrome2016BreakthroughDF,
  title={Breakthrough drugs for the interface between psychiatry and neurology},
  author={Leslie Citrome},
  journal={International Journal of Clinical Practice},
  year={2016},
  volume={70}
}
  • L. Citrome
  • Published 1 April 2016
  • Psychology, Medicine
  • International Journal of Clinical Practice
The US Food and Drug Administration (FDA) has made several different options available for the expedited review or ‘special handling’ of drugs and biologics (1–3). One option is called Breakthrough Therapy status (1–3). Breakthrough Therapy status is available for ‘a drug that is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies’ (1). The… 
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