Life Sciences
New guidance provides definition for orphan device, offers alternative trial designs
Jun 26, 2024
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Life Sciences
FDA further blurs the line between biosimilars and interchangeables
Jun 21, 2024
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FDA finalizes guidance extending inspection authority to medical devices
Jun 20, 2024
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Commission proposes guidelines to flesh out the newly finalized Variations Regulation
Jun 20, 2024
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ICMRA gives early readout on collaborative assessment, hybrid inspection pilots
Jun 17, 2024
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Life Sciences
In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue
Jun 13, 2024
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