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FDA's new expedited drug program raises legal questions and concerns

FDA's new expedited drug program raises legal questions and concerns

Summary

The FDA has introduced a new program to speed up drug reviews, which is supported by President Donald Trump's administration. This program is facing criticism because some experts and staff worry it may not meet legal and scientific standards. The program aims to approve drugs faster, but there are concerns about safety and political influence.

Key Facts

  • The FDA's new program tries to shorten drug review times to as little as one month.
  • Some FDA staff and experts worry this may not allow enough time for proper safety checks.
  • Approval decisions traditionally involve FDA scientists and supervisors, but this program involves higher officials.
  • Concerns involve potential breaches of legal, ethical, and scientific standards.
  • The new program supports drugs that benefit "U.S. national interests."
  • Recent reports indicate two drugs under this program had delayed reviews due to safety concerns, including a patient death.
  • The White House supports the program, seeing it as a way to offer treatments quickly.
  • The program's rules and procedures are not fully detailed in federal regulations.

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