adequate and well-controlled studies

adequate and well-controlled studies

the clinical and laboratory studies that the sponsors of a new drug are required by law to conduct to demonstrate the truth of the claims made for its effectiveness.
References in periodicals archive ?
There are no adequate and well-controlled studies of CellCept in pregnant women.
In an interview, a spokesperson from GlaxoSmithKline, which markets paroxetine under the brand name Paxil, said she could not comment directly on these findings, but noted that the company advises that no adequate and well-controlled studies of the drug have been conducted in pregnant or nursing women, and that Paxil should be used in these women only if the potential benefit justifies the risk.
NEW YORK, April 27 /PRNewswire/ -- Pfizer Inc (NYSE: PFE) said today that the Pulmonary-Allergy Drugs Advisory Committee concluded that there were sufficient adequate and well-controlled studies to support the safety and efficacy of the oral antihistamine Reactine (cetirizine).
The FDA has turned down the request, saying that "substantial evidence from adequate and well-controlled studies is lacking.
Typically, the FDA requires two adequate and well-controlled studies, each convincing on its own, to establish substantial evidence of effectiveness.
The data included in the NDA submission comes from four adequate and well-controlled studies, which utilized a double-blind, randomized, placebo-controlled design, and four supportive studies: one active-placebo-controlled study and three noncontrolled studies.