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On Medical Treatments & Products

NCHR Testimony on Vascepa to Reduce Risk for Cardiovascular Events

November 14, 2019. Drugs to help reduce the risk of cardiovascular events save lives. The REDUCE-IT study provides encouraging data that AMR101 [Vascepa (icosapent ethyl) ] may help, but there are some important concerns that must be addressed before approval.

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NCHR’s Comments on the USPSTF’s Recommendation on Screening for Bacterial Vaginosis in Pregnant Persons

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.

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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.

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NCHR Comment on FDA’s Draft Guidance on Developing Drugs for Male Breast Cancer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.

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