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    Japan's Conditional Approval Pathway for Regenerative Medicines

    This article discusses the history, reasoning, legal decisions and subsequent regulatory requirements behind Japan's bid to become a world leader in regenerative medicine. The authors outline the process for seeking new regenerative product approvals through an accelerated regulatory pathway and spell out the oversight role played by Japan's regulatory authorities to enable new regenerative, cell-based therapies to be made available to the public in Japan as soon as possi...
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    Melanoma Treatments: A History of US FDA Approvals

    Studying the history of regulatory approvals can provide insights into regulator expectations for new products. The authors undertook an investigation to examine the data sets on which previous US Food and Drug Administration (FDA) approvals for melanoma treatment products were based to determine whether trends have changed in the level of evidence provided. Melanoma was chosen due to its relevance to ongoing projects by the authors. Methodology The authors obtai...