FDA Related News

CDERs Requests for Intarcia Hearing

CDER submits a petition outlining its requests if the FDA chief scientist decides to grant Intarcia a hearing on its NDA for drug/device combination I...

Human Drugs

Karuna Mid-Year NDA Planned for Schizophrenia Drug

Karuna Therapeutics plans a mid-year NDA for schizophrenia drug KarXT (xanomeline-trospium) after reporting positive topline results from a recent Pha...

Marketing

Drug Promotion Research Landscape Analyzed

FDA and RTI International researchers review empirical studies of prescription drug promotion in the last decade and suggest areas for further study.

Medical Devices

Brainomix AI Stroke Tool Cleared by FDA

FDA clears a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence tool for stroke diagnoses.

Medical Devices

Viz.ai Algorithm Cleared for Abdominal Aneurysms

FDA clears a Viz.ai 510(k) for its Viz AAA, an artificial intelligence algorithm intended to detect suspected abdominal aortic aneurysms.

Medical Devices

CDRH Modifies Electronic 510(k) Portal

CDRH adds more functionality to its medical device electronic submission portal to prepare for an all-electronic submission process.

Human Drugs

FDA Input on Rare Disease Development Needed: PhRMA

Pharmaceutical Research and Manufacturers of America urges FDA to provide more input on the types of evidence that may be considered in rare disease d...

Medical Devices

Keep Device Real-World Evidence Under NESTcc: MDMA

Medical Device Manufacturers Association says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evi...

Human Drugs

Athenex Cell Therapy on Clinical Hold

FDA issues a clinical hold against Athenex and Baylor College of Medicines kUR-501 after the death of a young heavily pretreated male patient.

Medical Devices

Remote Assessments May Be Model for Device Inspections

Former CDRH Office of Compliance director Steven Silverman recommends device manufacturers look at FDAs remote regulatory assessment program as a temp...