FDA says it has cleared the Renuvion APR Handpiece for specific subcutaneous dermatological and esthetic procedures.
Michigan Gov. Gretchen Whitmer urges FDA to eliminate all REMS restrictions from the mifepristone abortion drug.
The Advanced Medical Technology Association urges the House and Senate to come to terms on a FDA user fee reauthorization package that includes diagno...
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Register notice: FDA determines that Fresenius Kabis Xylocaine (lidocaine hydrochloride) topical solution 4% was not withdrawn from sale due t...
FDA publishes a draft guidance on therapeutic equivalence evaluations.
Five stakeholders recommend changes to an International Council for Harmonization revised quality risk management guidance.
Researchers say the FDA Sentinel System may provide useful real-world data for cancer drug safety studies.