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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance.

Clinic 64
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Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health

FDA Law

Rates of chronic disease are high, as is obesity. Some insights come from an op-ed Kennedy wrote in the Wall Street Journal on September 5, 2024, setting forth some of his plans for a healthier America. Wise government officials will modulate their views as they learn new facts. Andrew J Shattock et al., To some degree.

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Not Only Harvard. RFK Jr.’s Slashed Science Funding Cuts Across States That Backed Trump

Physicians News Digest

including in most states that backed President Donald Trump in the 2024 election. We will leave no stone unturned in identifying the root causes of the chronic disease epidemic as part of our mission to Make America Healthy Again,” Hilliard said. 28, are in states Trump won in November.