Generics in JAMA
Difference in total area under the curve is within 3.25% of the innovator product for generic drugs approved in 1997, a review study by FDA published in the Dec. 1 Journal of the American Medical Association says. The agency examined 127 in vivo bioequivalence studies from the 273 generic drug approvals in 1997 for the study. "Practitioners and the public may be assured that if the FDA declares a generic drug to be therapeutically equivalent to an innovator drug, the two products will provide the same intended clinical effect," FDA Commissioner Henney wrote
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth