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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
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 development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More