منابع مشابه
Do Off-Label Drug Practices Argue Against FDA Efficacy
The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug's efficacy. The act requires efficacy certification for the drug's initial (" on-label ") uses, but does not require certification before physicians may prescribe for subsequent (" off-label ") uses. Are there good reasons for this inconsistency? Using a sequential online surve...
متن کاملFDA preemption of drug and device labeling: who should decide what goes on a drug label?
The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label sh...
متن کاملAssessing the FDA via the Anomaly of Off - Label Drug Prescribing
I t is commonly thought that the U.S. Food and Drug Administration (FDA) regulates the use of all pharmaceutical drugs in the United States. In fact, most hospital patients are given drugs that are not FDA-approved for the prescribed use. The FDA does require that drugs undergo extensive testing before they are released onto the market and, if it concludes that a new drug is unsafe or not effec...
متن کاملRegulating off-label drug use--rethinking the role of the FDA.
The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. For prescription drugs, the FDA approval process requires substantial evidence of efficacy and safety for specific clinical situations. Although approval is indication-specific, the FDA has a limited role once a drug is on the market. Recent draft guidelines covering manufacturers'...
متن کاملFDA drug approval summaries: fulvestrant.
Patients with hormone-sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following progression or relapse after tamoxifen therapy. Fulvestrant (Faslodex((R)), ICI 182780, AstraZeneca Pharmaceuticals; Wilmington, Delaware) is a selective antagonist of estrogen designed to have no estrogenic effects. Lack of aqueous solubility led ...
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ژورنال
عنوان ژورنال: Nature
سال: 2009
ISSN: 0028-0836,1476-4687
DOI: 10.1038/4601069a