US FDA's Regulatory Flexibility To Be Tested As Delcath Overhauls Melphalan Trial Design
Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.
You may also be interested in...
Commissioner tells House hearing that agency study found troubling drop in innovative competition; clinical trial reform, including encouraging surrogate markers, could speed development of products that may create pricing pressure on brands.
FDA’s “complete response” letter requesting further studies is no surprise after a scathing ODAC assessment in May, but with an interim CEO team in place, the company says it’s ready to work things out with regulators.