Sentence examples for were 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.

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.

Ophthalmic therapeutics were approved based on varying levels of evidence.

Only a small minority of drugs (7%) were approved based on phase II trials.

PCV7 was the first conjugated vaccine with published efficacy studies for IPD; PCV10 and PCV13 were approved based on immunogenicity comparisons with PCV7.

For example, the most widely used DMDs for relapsing-onset MS were approved based on the pivotal clinical trials where the average age of patients was 35 and those over the age of 50 or 55 were excluded [ 14– 16].

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.

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".