USA – New FDA Guidances Target Women’s Health, Neonatal Care

The US Food and Drug Administration (FDA) on Wednesday issued three final guidance documents to aid the development of new drugs for uncomplicated urinary tract infections (uUTI), bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), and draft guidance to encourage new therapies for newborns.

The final guidances focus on BV, which according to the CDC, is reportedly the most common type of vaginal infection, followed by VVC. The prevalence of uUTI is reportedly high in the US too.
 
Each final guidance is largely the same as its respective draft version, particularly for the one on developing drugs for uUTIs, first drafted in May 2018.
 
In terms of changes between the draft and final BV guidance, FDA said: “Changes in this final guidance include clarification about the timing of the primary efficacy endpoints, which are based on the intended treatment duration and the half-life of the topical or systemic drug. Minor edits were included for better clarity, such as guidance applicability to both topical and systemic drugs.”…