Sentence examples for approved population from inspiring English sources

It said that the approved population had been narrowed to those with the most severe disease and that the company would be required to monitor the outcomes of patients treated with Glybera and provide that data to regulators.

If a novel biomarker is to be used, and the product's labeling defines the approved population by this measure, regulations require that the means of measuring the biomarker be commercially available.

Information is therefore required on a drug's effect in the approved population.

In a statement yesterday, Amgen said it strongly believed its drugs were "safe and effective medicines when used in approved populations consistent with label dosing recommendations".

In 1996, the Food and Drug Administration FDAapprovedved population-wide fortification of milled grain at 140 μg FA/100 grams [ 9] to deliver an additional 100 μg/d of FA to the average adult diet [ 10].

As the editor of a popular Italian Catholic Web site put it recently, "The road the church is heading down is precisely this: To quietly approve population control while talking about something else".

†Subpopulation of clinical study covering approved patient population (10 cases) or reflecting patient population treated with appropriate comparator treatment (three cases).

†Subpopulation of clinical study covering approved patient population (10 individual assessments) or reflecting patient population treated with appropriate comparator treatment (three individual assessments).

The analysis focused on the approved patient populations (total study populations or subpopulations).

Supplements that expanded a drug's approved patient population were supported by the fewest active comparator trials and studies using clinical outcome endpoints.

19 Clinical studies in which a drug was used outside the scope of the approved patient population may overestimate or underestimate a drug's benefit or harm.