FDA Issues Guidance on Development of Drugs for Monkeypox

The FDA is issuing a new guidance to support sponsors in the development of drugs for monkeypox (mpox). The guidance is intended to provide nonclinical, virology, and clinical considerations for mpox drug development programs, targeting on recommendations to support initiation of clinical trials.

In the past, FDA has approved drugs for the treatment of smallpox under regulations commonly referred to as the Animal Rule, but this pathway is not applicable to drugs for mpox because the research team can design and implement clinical trials for mpox that are both ethical and feasible.

The FDA’s guidance documents do not establish legally enforceable responsibilities but instead describe the Agency’s current thinking on a topic and should only be viewed as recommendations.

Source: FDA