FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect

The FDA is announcing that today, the unified HFP, a new model for field operations and other modernization efforts is now in effect. This is the single largest reorganization in…

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Streamlining Site Feasibility and Start-up: Overcoming Challenges and Embracing Innovation in Clinical Research

In the ever-evolving landscape of clinical research, site feasibility and start-up processes remain critical yet challenging aspects that can significantly impact study timelines, costs, and overall success. In a recent…

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Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications Guidance for Industry, IRBs, and Clinical Investigators

This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs or biological products for the treatment of cancer. Specifically,…

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