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Federal Register notice: FDA determines that Fresenius Kabis Xylocaine (lidocaine hydrochloride) topical solution 4% was not withd...[ Price : $8.95]
FDA publishes a draft guidance on therapeutic equivalence evaluations.[ Price : $8.95]
Five stakeholders recommend changes to an International Council for Harmonization revised quality risk management guidance.[ Price : $8.95]
Researchers say the FDA Sentinel System may provide useful real-world data for cancer drug safety studies.[ Price : $8.95]
FDA classifies as Class 1 a Smiths Medical recall of its Medfusion 3500 and 4000 Syringe Infusion Pumps due to eight software malf...[ Price : $8.95]
CDER Office of Quality Surveillance director Jennifer Maguire explains the agencys surveillance testing and sampling program.[ Price : $8.95]
FDA tells Soleno Therapeutics that a change in study design for its Prader-Willi treatment NDA has the potential to answer agency ...