
FDA Revises Guidance on HABP and VABP Drugs
FDA releases draft guidance on the development of drugs to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia.
FDA has issued
The new draft guidance is a revision of the November 2010 guidance Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment, including changes to the primary efficacy endpoints, the enrollment criteria, the suggested primary efficacy analysis populations, and the noninferiority margin justification. The draft guidance, however, does not discuss statistical analysis or clinical trial design.
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