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Human Drugs

Sentinel May be Useful in Short Latency Cancer: Study

Researchers say the FDA Sentinel System may provide useful real-world data for cancer drug safety studies.

Medical Devices

Smiths Medical Recall of Infusion Pumps is Class 1

FDA classifies as Class 1 a Smiths Medical recall of its Medfusion 3500 and 4000 Syringe Infusion Pumps due to eight software malfunctions.

Human Drugs

CDER Sampling/Testing Program Explained

CDER Office of Quality Surveillance director Jennifer Maguire explains the agencys surveillance testing and sampling program.

Human Drugs

Soleno Study Change Might Answer Questions: FDA

FDA tells Soleno Therapeutics that a change in study design for its Prader-Willi treatment NDA has the potential to answer agency questions about the ...

Human Drugs

Draft Dose Banding Guidance Out

FDA publishes a draft drug banding guidance.

Medical Devices

FDA Warning on Ultraviolet Wands for Disinfecting

FDA issues a safety warning about certain brands of ultraviolet wands used for disinfecting surfaces because the devices may expose users and others t...

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Marketing

Many Drug Field Contacts In Person Again: Veeva Report

The Veeva Field Trends 2022 report says 75% of healthcare providers want contact with drug field staff to be a mix of digital and in-person.

Medical Devices

Transcranial Magnetic Stimulation Cleared for Anxiety

FDA clears a Neuronetics 510(k) for a new indication for its NeuroStar Advanced Therapy for Mental Health device, a transcranial magnetic stimulation ...

Human Drugs

CGMP Deviations at Bioiberica

FDA warns Spains Bioiberica about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

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Human Drugs

False/Misleading Claims for Imprimis Rx Compounded Drugs: FDA

FDA warns Imprimis Rx that professional promotional materials for a compounded ophthalmic drug make false and misleading statements about the drug.