FDA

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

Business News: AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

– Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for patients who are ineligible for intensive chemotherapy – VENCLEXTA is now approved in the U.S. for use in two different blood cancers: newly-diagnosed AML and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) – … Continue reading Business News: AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

FDA News: FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

WASHINGTON – The U.S. Food and Drug Administration today alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.  Complications may include dosing errors, pump failure, opioid withdrawal, infection and … Continue reading FDA News: FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

NAACP News: NAACP statement on FDA plan to ban sale of menthol, e-cigarettes

BALTIMORE, MD – NAACP released the following statement following reports of the Food and Drug Administration’s proposal to ban menthol cigarettes: “The NAACP is pleased to hear of the Food and Drug Administration’s (FDA) plan to ban the sale of menthol cigarettes and restrict the sale of flavored e-cigarettes.  For decades, data have shown that … Continue reading NAACP News: NAACP statement on FDA plan to ban sale of menthol, e-cigarettes