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.
Read More »NCHR Comment on FDA’s Draft Guidance on Developing Drugs for Male Breast Cancer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.
Read More »Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants
October 23, 2019. The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons. The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make.
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