FDA’s release of the long-awaited first set of guidances
on the new biosimilar development pathway in the U.S. offers a good opportunity to reflect on how the new 351(k)...
Biosimilars: Inverting the Innovator Development Model
When it comes to the new biosimilar pathway, it’s the IND—not the BLA—that matters.
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The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
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The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.
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Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.