Antibiotic Development: US FDA Needs Draft Guidance On QIDP Designation, GAO Says

After reviewing the actions the US FDA has taken to encourage development of new antibiotics over the last four years, the US Government Accountability Office (GAO) concluded that the agency should issue specific guidance on its qualified infectious disease product (QIDP) designation.

In a report, GAO also recommends that the agency clarify how drug sponsors should use draft guidance documents for antibiotic development. It says drug sponsors are uncertain how much they should rely on these documents