Sentence examples for approvals are based on from inspiring English sources

One view is that the heart's approvals are based on judgments about how best to satisfy the agent's desires in the long term.

Often, approvals are based on filtered or fraudulent reports by the industry.

These approvals are based on results from the randomized, phase 3 SELECT trial.

The approvals are based on clearly laid-out regulatory requirements [ 20].

These approvals were based on improved survival in the SHARP trial and the parallel Asian phase III trial [ 6, 49].

We reviewed the drug approvals produced by the FDA for four diseases, from 2003 to 2012, to learn how often these approvals were based on surrogate outcomes, and whether and how the rationale for using surrogate outcomes was discussed.

These approvals were based on the results from two phase 3 Controlled Myelofibrosis Study with JAK Inhibitor Therapy (COMFORT) studies [ 56– 58] showing that ruxolitinib was generally well tolerated and demonstrated rapid and durable clinical benefits, as well as a survival advantage.

14 15 We did not observe a change over time from 2003 to 2012, as to what type of outcomes the drug approvals were based on or how they justified the use of surrogates.

Regulatory approvals were based on the results of a single pivotal phase 3 study, which demonstrated a statistically significantly reduction in 28-day all-cause mortality (absolute risk reduction compared with placebo 6.1%, relative risk reduction 19.4%; P = 0.005) [ 4], with supporting data from a single phase 2 study [ 5].

Most orphan drugs submitted for regulatory approval are based on RCTs that follow generally accepted rules and guidance.

There was no significant relationship between annual cost and year of approval for drugs approved for treatment of acute lymphoblastic leukaemia (p=0.38); however, exclusion of the most recently approved drug of which approval was based on a historical perspective (Xaluprine) resulted in a significant relationship being observed (p=0.01).