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Federal Register

Panel to Discuss Certain Accelerated Approvals

Federal Register notice: FDA announces a 9/22-23 Oncologic Drugs Advisory Committee meeting that will discuss an NDA for Spectrum Pharmaceuticals pozi...

Federal Register

Topical Xylocaine Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Fresenius Kabis Xylocaine (lidocaine hydrochloride) topical solution 4% was not withdrawn from sale due t...

Human Drugs

Therapeutic Equivalence Evaluation Guidance

FDA publishes a draft guidance on therapeutic equivalence evaluations.

Human Drugs

Comments on ICH Quality Risk Management Guidance

Five stakeholders recommend changes to an International Council for Harmonization revised quality risk management guidance.

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...