5 topics to watch as MDUFA negotiations restart

MedTech Dive, Jan 13, 2025: MedTech outlines 5 key issues as MDUFA negotiations restart, including FDA staffing, device safety and effectiveness, and transparency. The article highlights growing concern from NCHR’s Diana Zuckerman and other patient and consumer groups that safety and effectiveness may receive less attention than faster device approvals.

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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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The FDA Commissioner Is Missing the Point of Advisory Committees

MedPage Today, November 22, 2025: 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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What the shutdown’s end means for FDA

Politico, November 14, 2025: Politico quotes experts’ questions regarding FDA Commissioner Makary’s plausible mechanism pathway described in NEJM. NCHR Diana Zuckerman doubts insurance would pay for such expensive drugs based on “plausible mechanism” rather than evidence that they are safe and effective.

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