In 1957, he applied for a visa to Kuwait (at the time a British protectorate) and was approved, based on his work in civil engineering.
"Washington's request... [for a waiver] was approved based on Washington's commitments to carry out certain actions in support of key education reforms... Washington was not able to keep all of its commitments," Duncan wrote in a letter sent Thursday to Washington Superintendent of Public Instruction Randy Dorn.
While toceranib was approved based on its demonstrated activity against canine mast cell tumors (MCT), activity against various other tumor types has been documented including several types of carcinomas [ 1, 3, 6].
Both sipuleucel-T (Provenge™, Dendreon Corporation, Seattle, WA, USA) and ipilimumab (Yervoy™, Bristol-Myers Squibb, PriNJeton, NJ, USA) were approved based on significantly improved patient survival versus control treatment in clinical trials.
The ophthalmic drugs in our study cohort were approved based on a median of two pivotal trials, compared with a median of one pivotal trial per device approval.
For example, an insulin biosimilar could be approved based on a study in people with type 1 diabetes, but upon approval, it would receive approval for use in all patient populations for which the reference product has been approved (e.g., type 2 diabetes, pediatrics).
The result is a "predicate creep," the report said, in which devices are approved based on information from older devices that often bear little resemblance to each other.
One contentious provision, for example, directs the FDA to assess whether new drug uses, or indications, could be approved based on "real-world evidence", such as observational studies.
While there is no evidence that any of the drugs stem the underlying disease, they were approved based on studies showing temporary improvement or stabilization in some patients with Alzheimer's.
Avastin had been approved based on a trial that showed it delayed the worsening of tumors by 5.5 months — almost as big a gain as seen now with pertuzumab.
"However, per the FDA definition, it is approved based on evidence of safety and probable benefit".
