While there has been an increased focus on dose selection problems in oncology, the issue also occurs in other therapeutic areas and the US Food and Drug Administration will be paying closer attention at the investigational stage so sponsors are not forced to redo clinical trials.
Improper Dose In Phase II Trials Can ‘Make Or Break’ Drug Program, FDA’s Stein Says
Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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