A San Francisco, California-based food company, Fong Kee Tofu Co., Inc., and its owners, Jen Ying Fong, Suny Fong, and Yan Hui Fan, have agreed not to process or distribute food until it has been demonstrated to the U.S. Food and Drug Administration that its facility and practices comply with federal food safety requirements.
Category Archives: Drug Safety Information Podcasts
FDA permits marketing of fecal incontinence device for women
The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
New data shows test can help physicians remove patients with suspected TB from isolation earlier
The FDA today cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be kept in a hospital airborne isolation room.
FDA clears system to reduce stroke risk during stent and angioplasty procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.
FDA approves Lucentis to treat diabetic retinopathy in patients with diabetic macular edema
The U.S. Food and Drug Administration today expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
Federal judge approves consent decree with Maquet Holding B.V. & Co.
A federal judge from the U.S. District Court for the District of New Hampshire has entered a consent decree of permanent injunction against Maquet Holding B.V. & Co. KG (Maquet), and two of the company’s officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies, which are also named on the consent decree: Atrium Medical Corporation (Atrium) in Hudson, New Hampshire; Maquet Cardiovascular, LLC (Maquet CV) in Wayne, New Jersey; and Maquet Cardiopulmonary AG (Maquet CP) in Rastatt and Hechingen, Germany.
FDA approves first tissue adhesive for internal use
The U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use.
FDA approves Ibrance for postmenopausal women with advanced breast cancer
The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.
FDA seeks $4.9 billion for FY 2016 to implement the FDA Food Safety Modernization Act and improve the quality and safety of the medical products Americans use
The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget – a nine percent increase over the enacted budget for FY 2015. The overall request includes $147.7 million in budget authority for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act and the management of critical medical products issues.
FDA expands uses of Vyvanse to treat binge-eating disorder
The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.