Food and Drug Administration at Regulatory Affairs Syndicator

Author Archive for Food and Drug Administration

HHS and FDA Announce New Tools to Help Consumers Use the Nutrition Facts Label

Closed Published by Food and Drug Administration November 14th, 2006 in Regulatory Affairs

Make Your Calories Count is an interactive online learning program that is also available in a downloadable format. The program guide features an animated character called “Labelman” who expertly leads the viewer through a series of exercises on the food label.

Wilkins-Rogers, Inc. Issues Allergy Alert on Undeclared Milk in Washington Seafood Breader

Closed Published by Food and Drug Administration November 13th, 2006

Washington Seafood Breader was distributed in Maryland, Virginia, Delaware, Pennsylvania, New York, New Jersey, Maine, North Carolina, and Missouri through retail outlets.

Endologix Announces Limited Voluntary Recall Of Visiflex 155 Mm Delivery Catheters

Closed Published by Food and Drug Administration November 13th, 2006

Based on a single field occurrence due to the failure of a catheter component manufactured by a third party, the Company has determined that these catheters should be recalled.

FDA Informs Public of Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets

Closed Published by Food and Drug Administration November 9th, 2006 in Regulatory Affairs

The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall being conducted by Perrigo Company (Perrigo) of Allegan, Michigan for 383 lots of acetaminophen 500mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets.

FDA Announces Actions to Strengthen its Postmarket Program for Medical Devices

Closed Published by Food and Drug Administration November 9th, 2006 in Regulatory Affairs

The U.S. Food and Drug Administration (FDA) has announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.

FDA Seeks Injunction of Seafood Processor

Closed Published by Food and Drug Administration November 6th, 2006 in Regulatory Affairs

The government’s complaint, filed today by the United States Department of Justice in the U.S. District Court for the District of Minnesota after settlement talks failed, charges the defendants with violating the Federal Food, Drug, and Cosmetic Act by processing seafood products under conditions that may cause the food to become injurious to health.

FDA Notifies Consumers that Tomatoes in Restaurants Linked to Salmonella Typhimurium Outbreak

Closed Published by Food and Drug Administration November 3rd, 2006 in Regulatory Affairs

To date, 21 states have reported 183 cases of illnesses to the CDC.

Archway Cookies LLC Recalls Small Number of Classic Oatmeal Big Batch Homestyle Cookie Packages

Closed Published by Food and Drug Administration November 3rd, 2006

The cookies subject to recall are Archway Classic Big Batch Homestyle Cookies. Each package bears the date code Best Before Jan 11 07 AX.

FDA Issues Advice to Consumers to Reduce Risk of Foodborne Illness from Fresh Produce

Closed Published by Food and Drug Administration November 2nd, 2006 in Regulatory Affairs

As it investigates an outbreak of illnesses that may be related to Salmonella typhimurium bacteria in produce, the U.S. Food and Drug Administration is reminding consumers of steps they can take to keep their food safe.

Stephen Mason to Join FDA�s Office of Legislation

Closed Published by Food and Drug Administration November 2nd, 2006 in Regulatory Affairs

Stephen Mason, a former Director of Government Relations at the Generic Pharmaceutical Association (GPhA) is joining the Food and Drug Administration (FDA) as a Senior Advisor in the agency�s Office of Legislation, effective November 13, 2006.

Boston Salads and Provisions Co., Inc. Recalls Cole Slaw Because of Possible Health Risk

Closed Published by Food and Drug Administration November 2nd, 2006

Boston Salads Cole Slaw Salad is available for purchase in the deli section of select supermarkets and delicatessen and convenience stores under the Boston Salads and Provisions Co., Inc., Dietz and Watson Inc., Hummel Brothers, Inc. label in the following states: Massachusetts, Rhode Island, New Hampshire, New York, New Jersey, Connecticut, Pennsylvania and Delaware.

Consumer Alert: Undeclared Milk in Maizteca Mexican Bread

Closed Published by Food and Drug Administration November 2nd, 2006

The recalled Maizteca Mexican Bread comes in an uncoded plastic package. It was sold in New York.

Krisp-Pak Company, Inc. Recalls Fresh Cut Fruit Because of Possible Health Risk

Closed Published by Food and Drug Administration November 2nd, 2006

The recalled fresh cut fruit was distributed in the Hampton Roads and Richmond, VA areas and the Charlotte, Greensboro and Raleigh, NC areas through retail stores and foodservice distribution centers.

FDA Approves First Generic Metronidazole

Closed Published by Food and Drug Administration November 1st, 2006 in Regulatory Affairs

The Food and Drug Administration today approved the first generic version of MetroGel-Vaginal (metronidazole vaginal gel), a treatment for bacterial vaginosis.

FDA Announces Public Workshop on Marketed Unapproved Drugs

Closed Published by Food and Drug Administration November 1st, 2006 in Regulatory Affairs

FDA will hold a workshop on January 9, 2007, to provide information, clarification and guidance to sponsors seeking approval to legally market prescription and over-the-counter drugs through the New Drug Application (NDA), abbreviated New Drug Application (ANDA) and monograph processes.