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Story perspectives

FDA's Fast-Track Drug Program Faces Safety Backlash

1/18/2026

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Story summary
  • The FDA's fast-track drug review program, launched under U.S. President Donald Trump, faces safety concerns.
  • Internal documents show delays in reviewing two drugs after a patient death and adverse event reports.
  • Critics say the program risks politicizing reviews and undermining scientific standards.
  • The program has expanded to 18 drugs, but only one has been approved.