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FDA Turmoil: Pazdur Warns Fast-Track Approvals Risk Public Health

11/22/2025

Summary

Story summary

Dr. Richard Pazdur, appointed by U.S. President Donald Trump as FDA's top drug regulator, warns fast-tracked approval initiatives led by FDA Commissioner Marty Makary could jeopardize public health.
Makary argues reducing required studies will improve responsiveness, while Pazdur says multiple studies are essential for safety.
Pazdur also criticizes a program expediting approvals for national health priorities, saying it lacks transparency.
Tensions grow amid FDA turmoil, including layoffs and leadership changes.

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Story summary

Dr. Richard Pazdur, appointed by U.S. President Donald Trump as FDA's top drug regulator, warns fast-tracked approval initiatives led by FDA Commissioner Marty Makary could jeopardize public health.
Makary argues reducing required studies will improve responsiveness, while Pazdur says multiple studies are essential for safety.
Pazdur also criticizes a program expediting approvals for national health priorities, saying it lacks transparency.
Tensions grow amid FDA turmoil, including layoffs and leadership changes.