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Benefits/Challenges of Decentralized Trials: Commentary

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A new online commentary by two CDER Office of Medical Policy officials outlines the advantages and challenges of conducting decent...

Panel to Review Carvykti and Abecma sBLAs

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Federal Register notice: FDA announces a 3/15 Oncologic Drugs Advisory Committee meeting to discuss sBLAs for Janssens Carvykti an...

7 ex-FDA Commissioners Weigh In on Mifepristone

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Seven former FDA commissioners file an amicus brief with the Supreme Court urging that a lower court ruling restricting access to ...

AI in Clinical Decision Tools Will Challenge FDA: Califf

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FDA Commissioner Robert Califf says artificial intelligence (AI) embedded in clinical decision support or the integration of AI in...

2 Veterinary Medicine Guidances Published

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The Center for Veterinary Medicine issues two guidances on data element submission.

FDA OKs NeuroBo Obesity Drug Phase 1 Trial

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FDA says NeuroBo can start a Phase 1 trial of its DA-1726 weight loss drug.

Former FDAer Deb Autor Joins Consultants

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Former FDA deputy commissioner Deborah M. Autor joins consulting group Healthcare Innovation Catalysts as chief executive officer.

Adaptimmune BLA for Synovial Sarcoma Accepted

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FDA accepts for priority review an Adaptimmune Therapeutics BLA for afami-cel, an investigational engineered T-cell therapy for ad...

Diabetes Digital Health Comments

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Two stakeholders respond to FDAs request for comments on using digital health technologies to detect prediabetes and undiagnosed T...

GE Wireless Maternal/Fetal Monitor Cleared

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FDA clears a GE HealthCare 510(k) for its Novii+ Wireless Patch, an antepartum and intrapartum maternal and fetal monitor that mea...