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Nov 05, 2007
 |  BioCentury  |  Regulation

Defining a regulatory path for ABS

Defining a regulatory path for ABS

Defining a regulatory path for ABS
FDA's new draft guidance on developing drugs to treat acute bacterial sinusitis (ABS) provided a more detailed description of the patient population than the prior draft guidance released in 1998 and clearly states that the agency recommends only superiority trials for the indication. Key points from draft guidance are listed below. Source: FDA
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