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Feb 19, 2002
 |  BioCentury  |  Regulation

Reconsidering 'available therapy'

Often a product's fate at the FDA turns on the precise definition of a word or phrase, and ambiguity can lead to inconsistent or arbitrary regulatory actions. FDA has recently clarified the meaning of "available therapy" and some related terms, shedding some light on the standards that will be used in a variety of settings to determine whether products are significant improvements over current clinical practice.

"Available therapy" usually means treatment that is described on an FDA-approved label. But under a recently released draft guidance document, the agency says that off-label uses that are well-documented sometimes will be treated as available therapies.

According to the document, FDA's centers for drugs and biologics "have determined that in regulations and...

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