Sentence examples for the proposed indication from inspiring English sources

The second panel voted favorably 13 to 1 that the benefits of the WATCHMAN LAAC therapy do outweigh the risks for use in patients who meet the criteria specified in the proposed indication.

The number of PRC units transfused in each episode was recorded by nurses, along with the proposed indication and concurrent Hb level.

We defined an orphan drug as one designated as such in FDA's online orphan drug product designation database 16 for the proposed indication in the application.

The high proportion of patients who achieve durable responses and disease stabilization, together with the lack of deterioration of performance status and the observed tolerability profile, with myelosuppression as main toxicity, may justify further evaluations of this new oral drug in the proposed indication.

4 7 For both decisions, the views of the committees were divergent, with 15 members of PRAC stating that 'the balance of benefits and risks remained favourable subject to specialist supervision', and 10 members of CHMP stating that they 'find the benefit risk balance for strontium ranelate negative in the proposed indication'.

9 On September 12 , 2014 the FDA Endocrine and Metabolic Drugs Advisory Committee met and discussed the biologics license application (BLA) 125511, proposed trade name NATPARA (Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted for the proposed indication of replacement for endogenous parathyroid hormone (1-84) and long-term treatment of hypoparathyroidism.

This research will identify and evaluate the proposed indications for damage control surgery and damage control interventions in civilian trauma patients.

Repurposing or repositioning of existing drugs could overcome some of these obstacles and help in the rapid discovery and development of therapeutics for EVD, although this approach does not negate the need for some preclinical studies and clinical trials for validation of the proposed indications.

The results of these trials are submitted to regulatory agencies in order to seek approval to market the drug for a proposed indication.

There are multiple types of dressings, each of which have a proposed indication as well as certain known advantages and disadvantages.

Ximelagatran hepatic toxicity was a key feature leading the CRAC to conclude that the benefit risk ratio of ximelagtran was unfavorable for the three proposed indications.