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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. First, patients may be exposed to safety risks from a drug that subsequently fails to demonstrate clinical benefit.

Clinic

Clinic Relationship Provider IT

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

FDA Law Blog

NOVEMBER 18, 2024

Rates of chronic disease are high, as is obesity. In the meantime, this belief was followed for centuries by doctors, to the detriment of countless patients. Wise government officials will modulate their views as they learn new facts. Kennedy’s tag line is that he and Trump will “Make America Healthy Again.”

Appointment

Appointment Vaccination Patient-Centered IT

Primary Care Digest

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

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

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