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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...

Device GMPs Harmonized with International Standards

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FDA issues a final rule to amend the medical device GMP requirements of the Quality System regulation to harmonize and modernize t...

Abeona Pz-Cel BLA Moving Forward

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FDA has completed a bioresearch monitoring inspection and mid-cycle review meeting for the Abeona Therapeutics BLA for pz-cel.

Four FDA-483s Released

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FDA releases the forms FDA-483 issued following inspections at four drug manufacturing facilities in three countries.