Sentence examples for approved based on from inspiring English sources

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.

Will the agency have the courage to reverse course when a medical treatment that it approved based on preliminary evidence flops badly in follow-up 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.

"The F.D.A. approves based on safety and efficacy.

Betty Riess, a BofA spokeswoman, said only that the bank uses "supplemental scores" such as Credit Optics "to take into account alternative information in making a credit decision versus just declining or approving based on a less predictive FICO score".

For each drug approved based only on surrogates, we examined if the rationale for using surrogate outcomes was discussed or not (yes/no).

At present only one drug, ruxolitinib, has been approved primarily based on its ability to reduce splenomegaly and improvement of disease-related symptoms.

The proposal has yet to be approved, but, based on history, a betting woman would say it is almost inevitable.