Business · 29/07/1998

FDA Releases Draft Guidance Documents for Antimicrobial Drug Development

The FDA's Office of Drug Evaluation IV is releasing draft guidance documents for the development of antimicrobial drug products, aiming to help sponsors design clinical trials that determine the safety and effectiveness of these drugs in treating specific infections. The documents will be discussed at an upcoming meeting of the Anti-Infective Drugs Advisory Committee on July 29-31, 1998.