To encourage development of drugs to treat serious bacterial diseases in patients with an unmet medical need, the FDA has updated a 2017 guidance on antibacterial drug development, indicating the agency may be willing to accept more flexible development programs.

The 15-page draft guidance includes more detail on conducting noninferiority (NI) trials of antibacterial drugs for serious diseases that lack effective treatments. Since the 2017 final guidance was issued, the agency has approved new drugs that act against certain drug-resistant organisms, making it possible to conduct NI trials that include subjects with infections caused by certain drug-resistant organisms because an active control is now available.

The revised draft guidance does not address statistical analysis or clinical trial design.

Comments on the draft guidance should be submitted by July 24.

Read the draft guidance here: https://bit.ly/3ajXO4q.