Sentence examples for support the approval of from inspiring English sources

"We believe the clinical trial results demonstrated a favorable benefit/risk profile and support the approval of tofacitinib," the company said.

Information on the chemistry, manufacturing, and controls (CMC) for the drug product must be submitted to the Food and Drug Administration FDAA) to support the approval of original new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

Briefing materials prepared by the drug company Sarepta Therapeutics to support the approval of their drug last year cited Myozyme as an "approval precedent" that they hoped to follow.

That would help to drive home the lesson from this whole episode: that the evidence used to support the approval of a merger needs to be just as diligently and rigorously prepared as the evidence used to justify a rejection.

Based on the data comparing the two methods, the U.S. Food and Drug Administration has concluded that the DPD colorimetric method is appropriate to use to measure chloramine-T in water during pivotal efficacy trials designed to support the approval of chloramine-T for use in fish culture.

The case study, presented by Mark Fletcher on behalf of B&V, involved a model scenario for a clinical efficacy trial to support the approval of a Similar Biotherapeutic Product (SBP) as part of the required comparative clinical program against a Reference Biotherapeutic Product (RBP).

'They are from the pivotal clinical trials that supported the approval of risedronate for osteoporosis in many countries.

Councillors William Owen-Jones and Cameron Caldwell also received death threats after they supported the approval of the application to convert a warehouse into a mosque at a planning committee meeting last Wednesday.

"While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product," Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.

As a board member, in 2001, McNerney supported the approval of what by 2008 amounted to a $10 billion investment in the 787.

Collectively, the results from these trials supported the approval of pregabalin for the treatment of FM by the US Food and Drug Administration in June 2007.