Sentence examples for supplemental indication from inspiring English sources

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.

The two efficacy trials in eltrombopag's supplemental indication approval used placebo comparators and surrogate outcome endpoints.

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

We were left with 295 supplemental indication approvals relating to 164 unique drugs.

However, we found medical reviews for only 20% of all supplemental indication approvals during our study time period, with such information available for one of 26 supplemental indication approvals from 2013 and for none of 40 from 2014.

Our results indicate the importance of post-approval surveillance of drugs' supplemental indications, particularly those that expand the eligible patient population.

Ten supplemental indications were approved with no clinical efficacy trials (9 expanded population supplements and 1 modified indication supplement).

Results The cohort included 295 supplemental indications.

*Total n=295 supplemental indications and n=202 original indications for 164 novel therapeutic agents.

Setting Publicly accessible data on supplemental indications approved by the US Food and Drug Administration from 2005 to 2014.