November 4, 2019. Given the lack of convincing evidence that screening for bacterial vaginosis leads to a clinical benefit, NCHR supports the USPSTF’s caution in making a recommendation to screen for bacterial vaginosis in pregnant persons to prevent preterm delivery.
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NCHR Testimony on New Contraceptive Patch by Agile Therapeutics
October, 30 2019. The FDA held an Advisory Committee meeting to discuss the safety and effectiveness of a new contraceptive patch by Agile Therapeutics. The Committee voted that the benefits of the patch to prevent pregnancy outweigh the risks.
Read More »NCHR’s Comments on USPSTF’s Draft Recommendation Statement Concerning Interventions for Illicit Drug Use
October 28, 2019. While there is a need to reduce and prevent illicit drug use in children, adolescents and young adults, more research is needed to identify which interventions are most effective to achieve this goal without causing unintended harms. Recommending interventions before the effects are well understood could cause more harm than good.
Read More »NCHR Comment on FDA’s Draft Guidance on Developing Drugs for Male Breast Cancer
October 28, 2019. Increased diversity and inclusion in clinical trials are important, and we agree with the FDA guidance that male patients with breast cancer should be included in clinical trials.
Read More »NCHR Testimony on Makena to Reduce Risks of Preterm Birth
October 29, 2019. The mortality and morbidity associated with preterm birth is a serious issue, which puts children at risk for long-term developmental problems. Treatments that decrease risk for preterm birth and improve neonatal outcomes are needed, but any drug given for this purpose must accomplish this purpose without undue risks. Based on the evidence being discussed today, there is not consistent evidence that Makena does this.
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