There was no significant relationship between annual cost and year of approval for drugs approved for treatment of acute lymphoblastic leukaemia (p=0.38); however, exclusion of the most recently approved drug of which approval was based on a historical perspective (Xaluprine) resulted in a significant relationship being observed (p=0.01).
The approval was based on data from a nearly 18,000-patient study, called Jupiter, financed by AstraZeneca.
That approval was based on a 45-person trial that lacked a control group for comparing how well stents worked.
Synapse Biomedical of Oberlin, Ohio, said approval was based on clinical trials it financed for 86 patients with A.L.S. and a condition called chronic hypoventilation.
However, environmental and consumer groups have raised concerns over the advance of GM salmon, with Consumers Union telling the Washington Post that the FDA's approval was based on "inadequate science and unfounded assumptions".
The drug's approval was based on studies that showed it killed bacteria more quickly than a control group taking the standard regimen, but it did not measure whether in the end patients actually fared better on bedaquiline.
The F.D.A. said in a news release that the approval was based on an analysis of 96 patients in a clinical trial with locally advanced or metastatic basal cell carcinoma.
In the clinical trial on which the approval was based, women who received Avastin in combination with the chemotherapy drug paclitaxel went a median of 11.3 months before their cancer worsened or they died, in contrast to the 5.8 months for women getting paclitaxel, also known as Taxol, alone.
The agency confirmed on Wednesday that it had revoked the contract when it saw a draft of the inspector general's report, dated July 18, that found that VBP had not met the agency's requirements for the 8(a) contracting program and that VBP's approval was "based on documents submitted by VBP that were false or of questionable authenticity".
The U.S. Environmental Protection Agency backed the chemical industry last year in rejecting a petition from honeybee keepers who argued that one neonicotinoid should be withdrawn from the market on the grounds that the studies on which approval was based were inadequate.
Approval was based on the positive safety and efficacy results of four international clinical studies, the longest of which was 22 weeks in duration.
