The U.S. FDA said it published the final guidance for coordinated development of antimicrobial drugs and antimicrobial susceptibility tests in an effort to encourage developers of treatments and tests to coordinate their efforts. Such coordination would ideally come early in the development process for the treatment, and the agency said the developer of the treatment need not restrict such interactions to a single test maker. Test makers are encouraged to engage the FDA via the Q-Sub process, adding that the test sponsor should file the 510(k) for the test at least four weeks prior to the issuance of the approval for the treatment. The agency will hold a webinar on Feb. 12 to discuss the guidance, the draft form of which was issued in September 2016.
The U.S. FDA said it is evaluating recent information regarding potential long-term mortality for patients receiving treatment for peripheral artery disease with paclitaxel-coated balloons and stents. The agency cited a meta-analysis appearing in the Journal of the American Heart Association (JAHA) that noted an increased risk of death for these patients at two years. The FDA said it will continue its surveillance with an eye toward dose delivered, cause of death, and patient characteristics that may be associated with fatal outcomes. The JAHA article appears in the Dec. 6, 2018, online issue.