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FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.

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 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 authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

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.

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

FDA Commissioner statement on modernizing the 510(k) pathway by creating policies that rely on newer predicates with modern characteristics related to their safety and performance

FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption

FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health

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

The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).

FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.

FDA provides updates on medical device safety action plan describing recent actions we’ve taken to enhance device safety including implementation of NEST and registries on women’s health.

The FDA approved Gamifant (emapalumab-lzsg) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.