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Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

FDA Law Blog

He also specifically mentioned rare diseases here , in addition to his example of late-stage illnesses. He delivered sharp words on tobacco and e-cigarette imports, warning that foreign manufacturers are gaming our porous border by importing products that would be illegal in their own countries.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. That leaves us to speculate what the implications of this Assessment will be.

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A Review of H5N1

Alabama Academy of Family Physicians

In 1996, a variant of H5N1 was documented overseas that resulted in a severe illness in birds and was designated as highly pathogenic avian influenza (HPAI). Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

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COVID Updates: A Podcast with Peter Chin-Hong and Lona Mody

GeriPal

Our conversation covers: The current state of COVID Evidence for COVID boosters, who should get them, and preferences between Novavax and mRNA vaccines COVID treatments like Molnupiravir and Paxlovid Differences in COVID impact on nursing home residents and those with serious illnesses We wrap up with a “magic wand” question.