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Pharmaceutical companies completing research in pediatric populations said that the studies required have become more complex and more expensive since 2008. Read More
The future of drug development and regulatory approvals must include the use of real world evidence, according to FDA Commissioner Robert Califf. Read More
The lowest-cost patient-centered initiatives — such as involving advisory groups and offering patient counseling and education — led to the largest returns in clinical trial performance. Read More
The FDA published recommendations for clinical trial designs for patients with bladder cancer, with separate considerations for patients with and without active disease. The agency’s draft guidance focuses on developing drugs and biologics for non-muscle invasive disease that has not responded to treatment with bacillus Calmette-Guerin immunotherapy. Read More
The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More
Officials from the FDA and the National Institutes of Health, in cooperation with public, private and industry stakeholders, published a framework for defining the levels of evidence needed to support the regulatory qualification of biomarkers for drug development. Read More
The development process for biosimilar blood thinners no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More
The European Medicines Agency made several changes to a March guidance explaining the agency’s policy for publishing sponsors’ clinical trials data, including factors that could lead to rejection. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for broader uses of research methodologies, such as intervention and randomization, in real-world settings outside the typical venues of clinical trials. Read More