FDA Issued Three Guidance Documents Targetting Womens Health and Neonatal Care

02 August 2019

GMP News

The US Food and Drug Administration (FDA) 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for uncomplicated urinary tract infections (uUTI), bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), and draft guidance to encourage new therapies for newborns.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.”

For the VVC guidance, FDA said:

“Changes from the draft to the final include clarifying edits, such as to the introduction section and definition of VVC, which were made after consideration of docket comments received. This guidance also adds clarification around clinical trial designs and the timing of the primary efficacy endpoint, which is based on the drug’s half-life, and dosing regimen.”

In addition to the final guidances, the draft guidance on clinical pharmacology considerations for neonatal studies focuses on general and study design considerations related to study population, dose selection, formulation, sample size, data analysis and others. It supplements December 2014 draft guidance on pediatric studies.

“We are encouraging industry that when designing these studies, there should be input from a multidisciplinary team involved in neonatal care, including parents,”

FDA Office of Pediatric Therapeutics Director Susan McCune said of the 18-page draft.



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