Sentence examples for are approved based on from inspiring English sources

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.

Blood pressure lowering drugs are approved based on short term trials determining the absolute blood pressure reduction during trough and the duration of the antihypertensive effect after single or multiple dosing.

28 As long as the drugs are approved based on surrogate outcomes without knowing their effect on patient-centred outcomes, we will never be certain of their actual beneficial or harmful effects on patients.

Papers are approved based on their suitability for reconstruction and are also matched to the level of the team, based on the team's performance on the benchmark problems and their understanding of the material.

Our survey findings suggest that, for three of the diseases examined (COPD, diabetes and glaucoma), drugs are approved based on their treatment effects on surrogate outcomes, but that the FDA does not use a consistent approach for surrogates in order to evaluate these drug applications.

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).

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".