Sentence examples for basis for approvals from inspiring English sources

Regulatory submissions within the US Food and Drug Administration Summary Basis for Approvals, as well as European Public Assessment Reports, were searched for serious infections data for biologic DMARDs approved for moderate to severely active rheumatoid arthritis.

The agency questioned whether an improvement in progression-free survival was a sufficient basis for approval.

That seems like a modest basis for approval pending completion of additional clinical trials.

"Our current path to approval in early breast cancer is far too slow," Dr. José Baselga, physician in chief at the Memorial Sloan-Kettering Cancer Center, said on behalf of Genentech at Thursday's meeting in Silver Spring, Md. So the F.D.A. issued a draft proposal last year that would allow pre-surgery treatment to be used as a basis for approval rather than postsurgery treatment.

Obviously, safety and effectiveness should be the only basis for approval.

It addresses clinical trials designs needs to better demonstrate efficacy and effectiveness in cognitive impairment syndromes and in part the controversy over the currently approved cognitive enhancers by demonstrating that, by design, the clinical trials that were the basis for approval of current drugs could not speak to pragmatic effectiveness, utility, or worthiness of the marketed drugs.

Some of these RCTs have generated high quality PRO evidence forming the basis for approval (or support to approval) of drugs by the US Food and Drug Administration.

In general, a distinction is made for anticancer drugs when no established treatment exists: in this case, an SAT may be the basis for approval.

This provided the basis for approval of tamoxifen by the Food and Drugs Administration FDAA) for breast cancer risk reduction in the USA in 1998.

The FDA recently reported that end points other than survival were the basis for approval of most (68%) oncology drug marketing applications following regular approval, and for all the applications following the accelerated approval procedure.

A number of these RCTs have generated high quality PRO evidence and some of these have also formed the basis for approval (or support to approval) of drugs by the US Food and Drug Administration FDAA) by showing better PROs with a given treatment.