Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)

On 25 May 2022 the FDA published the draft Q&A guidance, revision 1. Comments may be submitted until 24 July 2022.

The purpose of this draft guidance is to assist sponsors in the clinical development of new antibacterial drugs and provide updates based on the availability of new therapeutic options for development programs.

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