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Topical Xylocaine Not Withdrawn Due to Safety/Efficacy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Register notice: FDA determines that Fresenius Kabis Xylocaine (lidocaine hydrochloride) topical solution 4% was not withdrawn from sale due t...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FDA publishes a draft guidance on therapeutic equivalence evaluations.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...
