Sentence examples for supplemental indication for from inspiring English sources

Furthermore, despite the limited data on which many supplemental indication approvals are based, legislation that recently passed the US House of Representatives threatens to further diminish the level of evidence needed to obtain a supplemental indication for an approved prescription drug.

Supplemental indications for drugs treating infectious diseases (48% (21/44) for supplemental indications versus 76% (31/41) for original indications; P=0.008) and psychiatric conditions (0% (0/34) versus 62% (8/13); P<0.001) were supported by a lower proportion of trials using active comparators than were original indications in these therapeutic areas.

5 6 In 2014 the FDA approved 40 new supplemental indications for already marketed drugs, compared with original approvals of 44 novel small molecule and biologic agents during the same period.

*Total n=294 supplemental indications and n=201 original indications for 164 novel therapeutic agents; no study comparator information for trials supporting supplemental indication approval for celecoxib (Celebrex) in July 2005 or original indication approval for fluvastatin (Lescol, Novartis, Basel, Switzerland) in December 1993.

The rate of active comparator studies was higher for oncology supplemental indications than for original indications for drugs in this disease category (55% (44/80) versus 32% (13/41); P=0.02) (table 3).

Moreover, Caspase-3 expression tests were only meant to act as supplemental indications of cell death, rather than relying on statistical analysis of the data for definitive conclusions.

2 Such statements are also needed for supplemental indication approvals.

We found that 80% of FDA medical reviews for supplemental indication approvals were not accessible.

We also used χ tests to compare efficacy trials for supplemental indication approvals with analogous data from the original indications.

Drugs granted orphan drug designations at the time of original approval had the same rates of active comparator and clinical endpoint use in subsequently approved indications, even when such supplemental indications were for non-rare conditions.

For each supplemental indication approval, we determined its primary therapeutic area by consensus.