Biotech Leaders Fear FDA Disruption Is Causing Delays

A letter to US Senate HELP Committee Chair Bill Cassiday sounds an alarm about irreparable damage to the FDA, signed by more than 200 biotech executives and investors.

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Key Takeaways
  • More than 200 biotech leaders, investors and patient advocates sent a letter to US Help Committee chairman Cassidy raising concerns about FDA disruption.
  • Delays are already occurring in industry's communication with regulators following mass layoffs.
  • Smaller biotech companies are particularly exposed to regulatory delays because financing is tied to development and regulatory catalysts.

A letter to US Senate Health, Education, Labor and Pensions (HELP) committee chairman Bill Cassidy, R-LA, from more than 200 biotech leaders, investors and patient advocates cites cases of disruptions at the US Food and

“The operating plans and development milestones of biotech companies leave little room for missing critical regulatory timelines due to unforeseen FDA delays,” the letter states

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