Stacy L. Chin breaks down new NIH policies that let some companies skip Phase 1 trials, raise budget caps, and add security restrictions. The agency is also tightening cybersecurity rules and pushing harder on commercializing research.
For instance, the NIH has now completely changed how clinical trial applications are being submitted. They've created a brand new pathway that allows some companies to skip Phase 1 entirely. They've also dramatically changed the budget ceilings, introduced new national security and foreign collaboration restrictions, along with new cybersecurity requirements, tightened up compliance rules, and now putting more emphasis on commercialization than ever before. There's a bunch of others after this too.
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