Simple pills get an FDA pass based on clinical trials involving only blood tests to ensure the active drug is present at the right levels.
Finally, five papers, including one presenting a meta-analysis, were based on clinical trials.
The agency did so based on clinical trials involving a large dose of mifepristone in the clinic, a dose of misoprostol in the clinic two days later, then a third clinic visit on the 14th day to verify that the embryo had aborted.
The recommendations were based on clinical trials involving more than 50,000 people.
Since then, the drug has become standard treatment for newly diagnosed lymphoma patients, based on clinical trials showing that it makes chemotherapy more effective.
All the antidepressant drugs were approved for marketing based on clinical trials in adults, but once they were on the market, doctors were free to prescribe them for any patients and any purpose.
Though he did not mention ImClone or any other company by name, Dr. Pazdur said in a panel discussion that the agency wanted to discourage companies from seeking regulatory approval for drugs based on clinical trials designed like ImClone's.
Based on clinical trials, Januvia was less likely than other oral antidiabetes drugs to cause weight gain or severe drops in blood sugar.
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.
Results: Of the 180 cases surveyed, 123 (68.3%) (95% CI, 61.5%-75.1%) were based on clinical trials of good methodologic quality (Category I).
Few large series from real-world populations exist in the contemporary era with fully mature survival data to confirm the indication based on clinical trials that patients with CRPC are surviving far longer than the historical estimates.
