Zdrowie i gospodarka · 20/03/2009

Draft Guidance for Industry on Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Community- Acquired Bacterial Pneumonia: Developing Drugs for Treatment." This draft guidance informs industry of FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of community-acquired bacterial pneumonia (CABP). This draft guidance does not address the development of drugs for other purposes or populations, such as treatment of patients with hospital-acquired pneumonia or ventilator-associated pneumonia. This draft guidance revises the draft guidance for industry entitled "Community-Acquired Pneumonia-Developing Antimicrobial Drugs for Treatment" published July 1998.