FDA

FDA News: FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

Products make unproven claims for treating multiple diseases and conditions SILVER SPRING, MD (STL.News) The U.S. Food and Drug Administration today posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new … Continue reading FDA News: FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

FDA News: FDA warns patients, doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

Silver Spring, MD (STL.News) The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage.  Medical … Continue reading FDA News: FDA warns patients, doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

FDA News: FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium

SILVER SPRING, MD – Jan. 23, 2019 – The U.S. Food and Drug Administration today permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.).  This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated … Continue reading FDA News: FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium

FDA News: FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

SILVER SPRING, MD – The U.S. Food and Drug Administration today released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly … Continue reading FDA News: FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications

FDA News: FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

SILVER SPRING, MD – Today, the U.S. Food and Drug Administration cleared 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 (OUD).  The reSET-O app is a prescription cognitive behavioral therapy intended to be used in addition … Continue reading FDA News: FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

FDA News: FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

New drug Vitrakvi targets specific receptor kinase that promotes tumors SILVER SPRING, MD – The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the second time the agency has approved a cancer treatment based … Continue reading FDA News: FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

SILVER SPRING, MD – The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention and state authorities, continues to investigate a multistate outbreak of E. coli O157:H7 infections associated with consumption of romaine lettuce in the U.S.  As of Nov. 26, 2018, this outbreak has resulted in 43 people becoming … Continue reading FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

WASHINGTON | FDA says it will overhaul criticized medical device system

WASHINGTON— U.S. health officials said Monday they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and related products. The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date safety and … Continue reading WASHINGTON | FDA says it will overhaul criticized medical device system