FDA Used Regulatory Loophole To Save Novartis' Farydak
FDA shoehorned third-line multiple myeloma therapy into accelerated approval program using loophole in concept of unmet medical need; maneuver also gave agency ability to define a do-over of development plan.
You may also be interested in...
‘Dangling’ Accelerated Approval Reviews Expand At US FDA
The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.
Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition?
A look at drugs the agency approved despite an advisory committee vote not to do so and how they compare to Biogen’s Alzheimer’s disease drug aducanumab.
Case Studies In FDA's Regulatory Interpretation Of Clinical Trials
For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.