Sentence examples for indication approval from inspiring English sources

Some expensive drugs, such as modern antifungal treatment, immunoglobulin, and modern chemotherapy, are paid independently from DRG if several criteria are fulfilled: drug belonging to a restricted list (<100, updated every year), formal indication approval by health authority, individual prescription, and central preparation by pharmacist.

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.

Finally, for each supplemental indication approval, we used the same classification frameworks to evaluate the characteristics of the major efficacy trials supporting the drugs' originally approved indications.

*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.

We then used the Drugs@FDA database to gather information on each supplemental indication approval's date and chemical type (small molecule or biologic).

Secondly, we assessed the clinical trial evidence supporting supplemental and original indication approvals by using FDA approved drug labels rather than the detailed FDA medical reviews.

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

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