FDA supports new antibiotic pathway

FDA supports the creation a new pathway for review and approval of drugs to treat infections that are not susceptible to existing drugs, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told BioCentury Thursday. The new pathway was proposed by the Infectious Diseases Society of America in a statement submitted to the House Energy and Commerce Committee's health subcommittee. Under the proposal, products designated as "Special Population Limited Medical Use Drugs" could be studied in abbreviated clinical trials for specific populations, such as patients with drug-resistant infections, and measures would be taken to limit off-label use. ...