FDA Review posts the Federal Register notices for the week ending 6/1/2018.
FDA clears a Medicrea Group 510(k) for patient-specific spinal cages through the extension of its UNiD ASI (Adaptive Spine Intelligence) technology to...
FDA approves an Eli Lilly and Incyte NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active...
Federal Register notice: FDA makes available a draft guidance entitled Development of a Shared System REMS.
Federal Register notice: FDA makes available a draft guidance entitled Waivers of the Single, Shared System REMS Requirement.
Apotex recalls one lot of fluticasone propionate nasal spray (50 mcg per spray) due to the potential for the product to contain small glass particles.
FDA approves an Aratana Therapeutics supplemental New Animal Drug Application for Nocita (bupivacaine liposome injectable suspension) to include its u...
Medtronic recalls its HeartWare Ventricular Assist Device (HVAD system) because of the possibility for an interruption to occur in the electrical conn...