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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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 Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants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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NCHR Testimony on Cefiderocol to Treat CUTI

October 16, 2019. While there is a need for new antibiotics, those products need to have sufficient evidence of efficacy and safety. To continue to be the “gold standard” for approval, FDA needs to maintain high standards of evidence for approval.

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