FDA Expert Panels Lack Balance in Pursuit of ‘Gold Standard Science’

BioSpace, September 8, 2025: NCHR’s Dr. Diana Zuckerman tells BioSpace that the new FDA expert panels, such as those on SSRI’s during pregnancy and hormone therapy for menopause are more biased than FDA Advisory Committees and lack nuance about complicated data. They send a message to industry about what changes FDA wants to make.

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After 10 Years, the FDA Is Still Letting Women Down

Drugwatch, August 14, 2025: This excellent article explains that FDA lets women down when they approve drugs and devices for cancer and many other serious diseases, which often don’t work well on women and can be harmful. The article quotes Dr. Diana Zuckerman and other experts, and provides examples of specific medical products that you may have used or want to avoid.

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FDA Panel Urges Caution, More Data on Dermal Filler Use in Decolletage Area

Medscape, August 14, 2025: Dr. Diana Zuckerman urged the FDA to require better research and quantify risk information at the Aug 2025 FDA Advisory Panel reviewing risks of dermal fillers in decolletage area above the breast. We agreed with panel members concerns that filler could interfere with cancer diagnosis and breastfeeding, and cause a stroke. We also pointed out that this cosmetic procedure can cause pain, swelling, bruising, and lumps could last weeks or months, which will undermine any cosmetic improvement. Panel members also focused on risks of interfering with cancer diagnosis and breastfeeding
problems.

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Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling

Regulatory Affairs Professional Society, August 11, 2025: This article published by the Regulatory Affairs Professionals Society provides an excellent summary of key responses to the FDA’s request for public comment on regulations for hernia mesh. It clearly shows the conflicting perspectives of the device industry and healthcare experts about patients’ need for specific information about the risks and benefits of hernia mesh.

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Medical device industry says future MDUFA hikes unsustainable

MedTech Dive, August 5, 2025: NCHR’s Diana Zuckerman and Patient, Consumer, and Public Health Coalition’s Tess Robertson-Neel are quoted in the MedTech Dive’s article about the MDUFA VI meeting at FDA in August 2025. Alex Baum of Coalition member Generation Patient is also quoted. They focused on including patient and consumer stakeholders in MDUFA negotiations and using user fees for post-market safeguards and other efforts to improve the quality of medical devices.

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