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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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 Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants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.
Read More »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.
Read More »NCHR Comments on USPSTF’s Draft Recommendation Statement on Screening for Cognitive Impairment in Older Adults
October 7, 2019. We agree with the USPSTF draft that current evidence is insufficient to assess the balance of benefits and harms of wide-spread screening for cognitive impairment in older adults who do not have recognized signs or symptoms.
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