The Greatest US FDA Advisory Committees: A Look Back At Tumult And Turning Points
With two landmark advisory committee meetings coming up, the Pink Sheet reflects on some of the most memorable panel meetings over the last 20 years.
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Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns"
Oncologic Drugs Advisory Committee votes 8-2 that data support efficacy of the product, which could be the first mesenchymal stem cell product to clear the agency. FDA's concerns include reliance on a pivotal Phase III single-arm study.
The first virtual US FDA advisory committee review of a drug application was nearly a disaster, but the second proved that the concept can work. Nevertheless, things are going to be very different for sponsors, even when the technology is perfected.
Northera was approved by FDA under the Subpart H accelerated approval pathway; the Indications and Usage section of the drug’s labeling notes the lack of efficacy data for treatment with the drug beyond two weeks.