Sentence examples for approval program from inspiring English sources

Committee members suggested that the F.D.A. had to act to maintain the integrity of the accelerated approval program.

The case of Iressa has raised questions about whether the F.D.A.'s accelerated approval program might be allowing ineffective or unsafe drugs on the market.

Such a system was set up in 2009, under the country's interior ministry; it is not the case that Israel has no such refugee approval program.

The agency, in a summary of its arguments, says that because it has already determined that the benefits of Avastin do not outweigh the risks, retaining the approval while the new study is conducted "would not be in the interest of the public health and would jeopardize the integrity of the accelerated approval program".

In addition, it utilizes an automatic approval program for certain leases.

There was good hand hygiene compliance amongst staff, and the hospital had an established antibiotic stewardship and approval program.

In states with environmental laboratory approval programs, approved or certified laboratories should perform sample analyses.

"It bears noting that pharmaceutical companies have been abusing expedited drug approval programs to get mediocre drugs approved for some time," she said.

There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009).

By contrast, few dermatology agents participated in any program, with only 6% (2/31) being granted priority review and none being associated with the orphan drug, fast track, or accelerated approval programs.

16 17 18 Given the widely recognized risks to public health inherent in approving prescription drugs for widespread use on the basis of limited data, the FDA's expedited drug development and approval programs were intended to be limited in scope, applying only to investigational agents offering the greatest promise of therapeutic advance to patients with no other reasonable therapeutic choices.