BOSTON — The approval of Vertex Pharmaceuticals Inc.’s Orkambi (lumacaftor/ivacaftor) is being hailed as a big stride forward in the treatment of cystic fibrosis. The Food and Drug Administration announced its approval of the drug just before the holiday weekend. Vertex noted that the medication is the first to treat the underlying cause of cystic fibrosis in
WASHINGTON — Pharmacies have a four-month extension — until November 1 — to comply with the full scope of new dispenser tracing requirements under the Drug Supply Chain Security Act (DSCSA). The Food and Drug Administration issued a guidance yesterday saying it would not take enforcement action until November against a pharmacy that receives any
ALEXANDRIA, Va. — The National Community Pharmacists Association (NCPA), American Pharmacists Association (APhA) and National Alliance of State Pharmacy Associations (NASPA) have asked the Food and Drug Administration to delay enforcement of a July 1 product tracing deadline for dispensers of pharmaceuticals. In a letter this week to the FDA’s Office of Compliance, the three
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
SILVER SPRING, Md. — The Food and Drug Administration’s regulatory policy for homeopathic medicines has worked effectively for the last 25 years to protect the public health and provide consumer access to safe homeopathic medicines, according to the American Association of Homeopathic Pharmacists (AAHP). AAHP, which represents 90% of the U.S. homeopathic market, made its
WASHINGTON — Zarxio (filgrastim), a cancer treatment from Sandoz Inc., has become the first biosimilar product approved in the United States. The Food and Drug Administration announced its approval of Zarxio, a biosimilar to Neupogen, an oncology product from Amgen Inc., on Friday. The move is being hailed as a watershed event that paves the
WASHINGTON — Dr. Margaret Hamburg, commissioner of the Food and Drug Administration, will step aside next month after nearly six years at the helm of the agency overseeing many of the nation’s most contentious public policy issues and products representing about 20% of every dollar spent by consumers. Hamburg, 59, said her decision to step
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
