Sentence examples for is approved based from inspiring English sources

"However, per the FDA definition, it is approved based on evidence of safety and probable benefit".

The modeling is approved based on a large number of tests on 304 stainless steel and is compared with SWT and FS models.

Interagency Finished Pharmaceutical Product Questionnaire The product is approved based on the information provided in the Product Questionnaire and the technical documentation submitted.

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.

The article shows how value of information analysis can be used to inform a range of policy questions including whether a new technology should be approved based on existing evidence, whether it should be approved but additional research conducted or whether approval should be withheld until the additional evidence becomes available.

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.