The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.
Statement from FDA Commissioner Robert Califf, M.D. announcing the acting director of the FDA Oncology Center of Excellence
The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”), which calls on the agency to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices to create the Oncology Center of Excellence (OCE). The OCE will expedite the development of novel combination products and support an integrated approach to tackle this devastating disease that touches so many American families.
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.
Federal Court orders California soy company to cease production due to food safety violations
The U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction on Friday, June 24, 2016, between the U.S. Food and Drug Administration and Wa Heng Dou-Fu & Soy Sauce Corporation requiring the business to immediately cease manufacturing and distributing food until it comes into compliance with federal food safety laws.
Federal Court orders California soy company to cease production due to food safety violations
The U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction on Friday, June 24, 2016, between the U.S. Food and Drug Administration and Wa Heng Dou-Fu & Soy Sauce Corporation requiring the business to immediately cease manufacturing and distributing food until it comes into compliance with federal food safety laws.
IKEA N.A. Services, LLC Issues Allergy Alert on Undeclared Milk, Almond, Hazelnut in the CHOKLAD MORK and CHOKLAD MORK 70% Dark Chocolate Bars, Net Wt. 3.5 oz.
IKEA recalls CHOKLAD MORK UPC Code 100293927003 and CHOKLAD MORK 70% UPC Code 1203080940009 Dark Chocolate Bars, Net Wt. 3.5 oz. are being recalled due to undeclared Milk, Hazelnuts and Almonds.
Purina Animal Nutrition Initiates Recall of Purina Medicated Sheep Feed due to Elevated Copper Level
Purina Animal Nutrition LLC of Arden Hills, Minnesota, is voluntarily recalling one lot of Purina Lamb Grower B30 Medicated Sheep Feed packaged in the green and white generic paper LAND O LAKES Feed bags.
Sunflower kernel recall impacts Nature Valley Protein Chewy Bars & Nature Valley Simple Nut Bars
General Mills announced today a voluntary national recall of four specific flavors of Nature Valley Protein Chewy Bars and Nature Valley Simple Nut Bars. The recall is being issued as part of sunflower kernel supplier SunOpta’s ongoing national recall for the potential presence of Listeria monocytogenes. General Mills has not received any direct consumer reports of confirmed illnesses related to this supplier issue.
Recall For Undeclared Allergen Taken as Part of FDA’s Safety Advisory Regarding Grain Craft Flour Recall
The Father’s Table of Sanford, Florida, is voluntarily recalling 2,099 cases of cheesecakes sold by Gordon Food Service through retail and food service outlets under the GFS label as a result of a recall by one of The Father’s Table’s flour suppliers, Grain Craft.
Read The Complete Story!