Draft Guidances for Industry on the Development of Antimicrobial Drug Products; Availability

Streszczenie

The Food and Drug Administration's (FDA's) Office of Drug Evaluation IV (ODE IV), Center for Drug Evaluation and Research (CDER), is announcing the availability of several draft guidance documents on the development of antimicrobial drug products. A general draft guidance document entitled ``Developing Antimicrobial Drugs--General Considerations for Clinical Trials'' discusses issues common to the development of all antimicrobial drugs. The companion draft guidance documents address issues related to developing drugs to treat individual indications. These draft guidance documents are intended to help sponsors design clinical trials that will yield information the agency can use to determine whether the antimicrobial drug under study is safe and effective in the treatment of the specific infection studied. Key elements of these draft guidance documents will be discussed at a July 29, 30, and 31, 1998, Anti-Infective Drugs Advisory Committee meeting.