Top drug regulator Richard Pazdur set to leave the FDA

STAT reports Pazdur sudden FDA retirement as CDER head as we agree with industry in questioning if FDA can function as a scientific and public health agency when it can’t keep dedicated staff amid controversial decisions on vaccines and other medical products.

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Hormone Therapy and Menopause: Facts and Fiction

Hormone therapy for menopause has risks and benefits. Research results are nuanced, despite FDA Makary and RFK claims that it improves most women’s health. Both risks and benefits depend on the woman’s age and medical history and genetics, the type of hormones, and other factors .

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The FDA Commissioner Is Missing the Point of Advisory Committees

Diana Zuckerman’s oped in MedPage Today says FDA was never perfect but the media and public could see how the agency reviewed risks and benefits when they held public meetings where scientists and public citizens debated controversial medical products. In recent months they’ve switched to one-sided rubber stamp meetings followed by announcements of their decisions at events that feel like pep rallies. For example, research shows that hormones for menopause can be helpful or harmful, depending on your age and the type of hormones and your personal medical history. They are not safe for everyone, and can cause cancer, strokes, and dementia for many women. But the FDA expert panel focused on the benefits and ignored most of the risks.

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Dr. Diana Zuckerman Testifies at FDA Advisory Committee on Digital Health

NCHR’s Dr. Diana Zuckerman testified at the FDA Advisory Committee meeting on Digital mental health products, expressing concerns about FDA’s failure to regulate the Chatbots and other digital products being marketed as “licensed therapists” and used as psychotherapists in ways that can be extremely harmful. She urged better research but acknowledged difficulty of studying devices that are updated frequently

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