Sentence examples for approval safety from inspiring English sources

As the faithful at Neyland Stadium roared with approval, safety Maurice Sikes stood in Miami's defensive huddle and apologized to his teammates.

I know approval, safety and security (click here to see #11 of the 15 Commitments of my current world) - as well as deep connection with the people I most love - comes from inside me and not from glittery possessions or credulous friends.

Across the 10 sponsor-initiated infliximab trials in IBD (five smaller studies and five pivotal phase 3 studies conducted following infliximab's initial approval), safety data for 2,385 patients were available for pooled safety analyses (see Tables 3, 4, 5).

Between 1999 and 2011, 19%% of 279 newly approved drugs in Europe were reported to have post-approval safety issues and five drugs had to be withdrawn from the market (Mol et al. 2013).

Indeed, the Institute of Medicine report said the F.D.A. devoted too much of its resources to reviewing new drug applications and not enough to tracking post-approval safety.

We use these to measure the effect of the program on time-to-market and post-approval safety risks to patients.

Post-approval safety data are useful for general screening to detect low-frequency safety signals through the exploitation of a larger user population, even from non-prespecified populations.

Nevertheless, there may be products that hold a greater risk of post-approval safety concerns, warranting a risk-based approach toward PSUR reporting requirements.

On the other hand, if the PSUR assessment process never results in some form of regulatory action, one can question whether PSURs are the most effective regulatory instrument to manage the post-approval safety of medicines.

This conclusion is in line with the results of a study which reported that a large proportion of post-approval safety warnings issued for biopharmaceuticals are related to their immunomodulatory effects [ 12].

We calculated the number of studies reaching regulatory recommendations for pre-approval safety assessment of drugs intended for long-term treatment of non-life-threatening conditions, i.e. 100 patients exposed for a minimum of 1 year or 300-600 patients for 6 months can be adequate to assess the pattern of ADEs over time [ 11, 12].