WASHINGTON — The Food and Drug Administration is again postponing the release of a final rule that would change generic drug labeling requirements. In a Federal Register notice this week, the FDA indicated that it aims to implement the final rule in April 2017, though many industry stakeholders had expected the agency to do so
WASHINGTON — Just over a year after approving its first biosimilar product, the Food and Drug Administration has approved its second, Celltrion’s Inflectra (biosimilar infliximab). Inflectra is a biosimilar to Janssen Biotech’s Remicade (infliximab), originally licensed in 1998. Inflectra is indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque
WASHINGTON — The U.S. Senate overwhelmingly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration. Califf, who was deputy commissioner for medical products and tobacco, was nominated as FDA commissioner by President Barack Obama in mid-September. No significant opposition was expected for his confirmation hearing on Tuesday, as the Senate voted 89-4
WASHINGTON — The Food and Drug Administration has established the Office of Dietary Supplement Programs (ODSP), raising the program from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements. The FDA said Monday that it’s also in the process of identifying permanent leadership for ODSP. Meanwhile, Bob Durkin will
WASHINGTON — To eliminate trans fat in processed foods, the Food and Drug Administration has called on food manufacturers to remove partially hydrogenated oils (PHOs) from products over the next three years. The FDA said Tuesday that, following “a thorough review of the scientific evidence,” it has concluded that PHOs — the primary dietary source
Margaret Hamburg WASHINGTON — Margaret Hamburg reportedly is stepping down as commissioner of the Food and Drug Administration. Published reports said Thursday that the 59-year-old Hamburg is slated to leave the FDA commissioner post at the end of March and that the Obama administration plans to make a formal announcement on Friday. Plans call for
WASHINGTON — The Healthcare Distribution Management Association (HDMA) is praising the Food and Drug Administration for its flexibility pertaining to new product tracing rules, specifically on the FDA’s recently released guidance titled “Product Tracing Requirements — Compliance Policy.” The association had sent letters to the regulatory agency in November and then again last month in
WASHINGTON — A Food and Drug Administration panel has recommended that the agency approve what could become the country’s first biosimilar. The panel unanimously urged approval of Sandoz’s filgrastin (Neupogen), a cancer treatment. “This encouraging step forward means that it is very likely now only a question of when, rather than if, filgrastin will be available
