Biotech & Pharma

STAT+: Pharmalot: We're reading about a lack of FDA adcomms, FDA loosening biosimilar rules, and more

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The FDA is facing criticism for significantly reducing advisory committee meetings under Commissioner Marty Makary's leadership, which has led to increased regulatory uncertainty and political involvement in scientific decisions. Additionally, the FDA plans to ease requirements for biosimilar drug development to boost competition and lower costs, potentially saving $20 million per new biosimilar drug. For content creators, these changes highlight shifting dynamics in pharmaceutical regulation and potential impacts on drug pricing and availability that may be of interest to their audiences.

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