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Publications (6)
In 1994, the US Food and Drug Administration (FDA) proposed an approach, based on extrapolation of efficacy findings from adults to the pediatric population, to maximize the use of adult data and other data when designing pediatric drug-development programs. We examined the experience of the FDA in using extrapolation to evaluate how and when it wa...
Risk of anaphylaxis is included in the prescribing information for omalizumab, but the nature of these reactions merits further elaboration.
To describe cases of anaphylaxis associated with omalizumab administration in patients with asthma.
We reviewed spontaneous postmarketing adverse event reports submitted to the US Food and Drug Administration'...
To the Editor: In late 2004, a “boxed warning” was added to the labeling for promethazine hydrochloride (Phenergan), including a contraindication for use in children less than two years of age and a strengthened warning with regard to use in children two years of age or older. We describe the basis for this action. Promethazine is widely used in ch...
To the Editor: Dr Dolor and colleagues¹ concluded that intranasal corticosteroids are efficacious in the treatment of acute rhinosinusitis. We believe, however, that the design of their trial significantly limits the conclusions that can be drawn from it.
We believe the trial design was more like that of a large simple trial rather than a well-cont...