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USA | FDA Accepts Wearable-Derived Foot-Drop Measure into ISTAND — Digital Outcomes Advance in Rare-Disease Development

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USA | FDA Accepts Wearable-Derived Foot-Drop Measure into ISTAND — Digital Outcomes Advance in Rare-Disease Development2026-10-18T12:59:39+00:00

USA | Natural-History Evidence Supports FDA Approval of First Gene Therapy for Sanfilippo Syndrome Type A

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USA | Natural-History Evidence Supports FDA Approval of First Gene Therapy for Sanfilippo Syndrome Type A2026-10-18T12:22:51+00:00

USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence

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USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence2026-09-12T14:52:08+00:00

USA | Reagan-Udall Foundation Meeting Summary Highlights Real-World Data Challenges for At-Home Diagnostics

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USA | Reagan-Udall Foundation Meeting Summary Highlights Real-World Data Challenges for At-Home Diagnostics2026-08-10T17:32:46+00:00

USA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework

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USA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework2026-08-10T16:40:04+00:00

USA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation

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USA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation2026-06-12T10:54:30+00:00
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