Regulatory Affairs Syndicator

Despite the recent E. coli spinach outbreak, food may be safer now than at any other time in the last decade, with illness occurring at record-low rates, new federal statistics show.
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HealthScout - A drug designed to prevent blood loss during certain types of heart surgeries appears to increase users’ risks of kidney failure, heart failure and stroke , the U.S. Food and Drug Administration announced Friday. The agency advised doctors to …

Most fresh spinach in the U.S. is “as safe as it was” before a nationwide E. coli outbreak, the U.S. Food and Drug Administration said, revising a two-week-old warning.

Dayton Business Journal - Food and Drug Administration found it didn’t meet federal manufacturing standards. Alpharma spent million of dollars to fix the problems but also scaled back the operation. The Lincolnton plant doesn’t share those obstacles, says Greg Sherwood …

Las Vegas Sun - A recent report says that the U.S. Food and Drug Administration is beleaguered by poor management and that its process for monitoring drug safety and approving new drugs needs a major overhaul. In its report released late last week, the Institute of …

Most fresh spinach in the United States is “as safe as it was” before a nationwide E. coli outbreak, the U.S. Food and Drug Administration said, revising a two-week-old consumer warning.

East Bay Business Times - The latest wrinkle drug from Allergan Inc. is set to be available to some doctors and patients as early as next week. Juvederm, which was approved by the Food and Drug Administration in June, will initially offer the injectable drug through select …

In response to a fourth case of botulism being linked to Bolthouse Farms, Bakersfield, California brand carrot juice, the Food and Drug Administration (FDA) is warning consumers not to drink Bolthouse Farms Carrot Juice, 450 ml and 1 liter plastic bottles, with “BEST IF USED BY” dates of NOV 11 2006 or earlier.

Most fresh spinach in the United States is “as safe as it was” before a nationwide E. coli outbreak, the U.S. Food and Drug Administration said, revising a two-week-old consumer warning.

Dallas Business Journal - The U.S. Food and Drug Administration again has extended its marketing approval for GlaxoSmithKline ’s epilepsy treatment Lamictal. London-based GSK said Wednesday that the FDA has approved the anti-seizure medication for use in treating one of the …

Amgen Inc., one of the biggest biotechnology firms by revenue, plans to expand its operations in Fremont after winning approval this week for a colon cancer drug that was developed by Abgenix Inc.
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Ledger - WASHINGTON, Sept. 29 — Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food …

Area grocery store shelves will be lined again with fresh spinach after the federal Food and Drug Administration deemed the vegetable safe for consumption - a month since an outbreak of E. coli killed one …
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Consumers again can dine on California-grown spinach despite an ongoing investigation that has yet to produce the source of bacterial contamination that killed at least one person and sickened 187 others in the …
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Labopharm feels market pain from delayed approval of new drugGlobe and Mail, Canada - 2 hours agoyesterday as the US Food and Drug Administration raised certain questions about its new pain medicine that could delay final approval for 60 days…