Summary:
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New Dosing Guidelines
The FDAβs Project Optimus calls for re-evaluating cancer drug doses to reduce side effects, requiring drugmakers to test lower doses for better safety and efficacy. -
Impact on Trials
The initiative may lead to larger and longer clinical trials, which some startups worry could increase costs and extend development times, putting them at a disadvantage. -
Regulatory Balance
While the FDA aims to improve patient safety, it reassures that it will work with drugmakers to expedite the approval process for new treatments.
Read more at: WSJ
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