FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.
Category Archives: Drug Recalls & Safety Notices
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety
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.
FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease
The FDA approved Gamifant (emapalumab) 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.
Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk
FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.
FDA approves new drug to treat travelers’ diarrhea
FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry
The U.S. Department of Agriculture and U.S. Food and Drug Administration are announcing that USDA and FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.
Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
The FDA is committed to making sure post-market studies are transparent to the public and that industry is fulfilling their PMRs and PMCs.
Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to reduce use of animals through a study aimed at eliminating the use of dogs in certain trials
FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.
Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year
New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018.