On October 23, 2025, FDA released its final guidance regarding Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments. The guidance is the ...
The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.
New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments.
Avik Pal, Founder and CEO of CliniOps, a technology and data company with multiple patents to digitize global clinical trials. When Michael J. Fox and Stephen Hawking publicly shared their personal ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing ...
WEST PALM BEACH, Fla. — Patient-reported outcomes (PROs) define the issues that matter to the patient, but their potential in multiple sclerosis (MS) is likely to remain unfulfilled until barriers, ...
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SISAQOL-IMI provides guidance for implementing patient-reported outcomes in cancer clinical trials
The SISAQOL-IMI consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), just announced the publication of its pivotal paper in The ...
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