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Health Agencies Update
July 16, 2003

Medical Illustrations on Display

JAMA. 2003;290(3):324. doi:10.1001/jama.290.3.324-a

The US Food and Drug Administration (FDA) has announced new regulations and internal reforms to streamline the approval of generic drugs.

The new rules limit drug companies to a single 30-month "stay" of a generic's entry into the market for resolution of a patent challenge. According to a 2002 Federal Trade Commission report, in at least six cases, pharmaceutical companies have blocked the development of generic equivalents of fast-selling drugs by pursuing multiple 30-month stays.

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