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 Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants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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NCHR Testimony on Singulair and Neuropsychiatric Side Effects

September 27, 2019. Singulair has serious side effects and we need much better data to determine the likely benefit and risk of harm for patients. FDA has an important role to play in encouraging this research. In the meantime, patients, parents, and clinicians must be given clear information about the risks so that they can make an informed decision about whether to use montelukast (Singulair).

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