FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.
Category Archives: Drug Recalls & Safety Notices
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework
FDA announces new actions advancing the agency’s biosimilars policy framework
Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.
FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs
FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder
Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs
FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
FDA releases new strategic framework to advance use of real-world evidence to support development of drugs and biologics
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products
Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new effort for developing and class labeling of vitro companion diagnostics for classes of oncology therapeutic products
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus
FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus
FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan
FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.