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Human Drugs

FDA Advancing Treatments for Children

FDA officials list ways in which the agency is promoting the development of pediatric medicines.

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Human Drugs

FDA Questions Y-mAbs Neuroblastoma Treatment Efficacy

FDA raises efficacy questions about a Y-mAbs BLA for I-omburtamab to treat pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.

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Medical Devices

Digital Health Regulatory Science Opportunities

The CDRH Digital Health Center of Excellence releases a document highlighting topics of interest for regulatory science research and partnerships.

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Human Drugs

GSK Scraps Monoclonal Antibody Development for RA

GSK decides not to seek FDA approval for otilimab, an investigational monoclonal antibody targeting granulocyte-macrophage colony-stimulating factor a...

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Federal Register

Info Collection on 3rd Party Review Program

Federal Register notice: FDA sends to OMB an information collection extension entitled 510(k) Third-Party Review Program.

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Human Drugs

FY 2023 GDUFA Research Priorities

FDA posts eight generic drug research priority initiatives for FY 2023.

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Medical Devices

Baxter WatchCare Urgent Correction

FDA says Baxter International has issued an urgent medical device correction for its WatchCare incontinence system that may cause radio interference w...

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Medical Devices

Developing, Responding to Device Deficiencies Guidance

FDA publishes a guidance to help agency staff request additional information needed to make decisions on medical device marketing applications.

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Medical Devices

MDIC Cybersecurity Maturity Benchmark Report

The Medical Device Innovation Consortium releases its first medical device manufacturer benchmark report on cybersecurity maturity.

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Medical Devices

Califf Hoping for LDT Legislation

FDA commissioner Robert Califf says he hopes Congress will include regulation of laboratory-developed tests and several other issues in a December fun...