The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.
Category Archives: Food Safety News
FDA approves implantable device that changes the shape of the cornea to correct near vision
The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.
FDA requests additional information to address data gaps for consumer hand sanitizers
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.
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!
Mondelēz Global LLC Conducts Nationwide Voluntary Recall of Limited Quantity of Honey Maid Teddy Grahams Cinnamon Cubs Product Sold in Foodservice Channels in the U.S.
Mondelēz Global LLC announced today a nationwide voluntary recall in the United States of the Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks sold only in Foodservice channels (not supermarkets). This recall is being conducted out of an abundance of caution following notification of a wheat flour recall by Grain Craft, a third-party flour supplier to one of our external manufacturers due to the potential for undeclared low levels of peanut residue in the flour.
Read The Complete Story!