The U.S. Food and Drug Administration today expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.
Category Archives: Drug Safety Information Podcasts
FDA grants accelerated approval to new treatment for advanced ovarian cancer
The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer.
FDA grants accelerated approval to new treatment for advanced ovarian cancer
The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer.
FDA approves Eucrisa for eczema
The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.
FDA approves Eucrisa for eczema
The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.
FDA Statement from Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, on new safety information on anesthesia use in young children and pregnant women
The health of our nation’s children is a responsibility that the FDA takes very seriously. Parents and caregivers are often concerned when their young child requires a medical procedure for which anesthesia or sedation drugs are necessary. Understandably, there are many questions, including whether the drugs are safe for their child. Pregnant women who must undergo medical procedures that require anesthesia or sedation drugs have similar concerns.
FDA Statement from Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, on new safety information on anesthesia use in young children and pregnant women
The health of our nation’s children is a responsibility that the FDA takes very seriously. Parents and caregivers are often concerned when their young child requires a medical procedure for which anesthesia or sedation drugs are necessary. Understandably, there are many questions, including whether the drugs are safe for their child. Pregnant women who must undergo medical procedures that require anesthesia or sedation drugs have similar concerns.
FDA takes action on applications seeking to market modified risk tobacco products
The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss. With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.
FDA takes action on applications seeking to market modified risk tobacco products
The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss. With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.
FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee
The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.