FDA released its 2004 Produce Safety Action Plan, "Produce Safety From Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption." The plan supercedes the agency's proposed action pl FDA released its 2004 Produce Safety Action Plan, "Produce Safety From...
The U.S. Food and Drug Administration FDA announced on November 10 its action plan for strengthening its monitoring of the safety of medical devices after they reach the marketplace. "Many of today's medical devices are smaller and more complex thaThe U.S. Food and Drug Administration FDA announced on November 10...
PHILADELPHIA -- Wolters Kluwer Health WKHealth, the leading drug and health information provider, today unveiled its new Integrated MedFacts Module for the Medi-Span product line, which will provide pharmacists and other healthcare professionals with the tools they need to help consumers understand their medications.
If you're not a chemist, chances are good you hadn't heard of acrylamide before April, 2002, when the Swedish National Food Administration reported its existence in a variety of fried and oven-baked foods. The Swedish research indicates that acrylami If you're not a chemist, chances are...
FDA reschedules Advisory Committeemeeting for liraglutide - no change of review timeline anticipated The US Food and Drug Administration FDA has informed Novo Nordiskthat the planned Advisory Committee meeting for liraglutide on 2March 2009 has been rescheduled to 2 or 3 April 2009. Novo Nordisk submitted the New Drug...
FDA meeting scheduled for November 17; Resubmission anticipated in December RALEIGH, N.C. -- BioDelivery Sciences International, Inc., (Nasdaq:BDSI) announced that a meeting with the Food and Drug Administration FDA is scheduled for November 17, 2008, to discuss its proposed Risk Evaluation and Mitigation Strategy REMS for ONSOLIS([TM]). ...
The Food and Drug Administration plans to open an inspection office in China by the end of the year. The agency's action is part of its plan to assure the safety of drug imports from the developing world...
New Effort Communicates Important Consumer Information, Continues Company's "Live Positively" Philosophy ATLANTA -- Coca-Cola North America today announced it plans to place calories-per-serving and servings-per-container information on the front of all packages for its entire U.S. beverage portfolio. Research shows that calorie information is an important tool to...
The FDA has notified Ipsen that it has extended the Prescription Drug User Fee Act action date for the company's approval application for using botulinum toxin drug Dysport to treat cervical dystonia to no later than Dec. 28. The company said the FDA's decision would not affect the...
Globalization of the Agency a Key Part of Import Safety Action Plan to Enhance Product Safety WASHINGTON -- The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration FDA staff to China, India, Europe, and Latin America before the end of...
The FDA issued a warning letter to Forest Labs for an eight-page journal ad for Bystolic, saying that the ad made unsubstantiated superiority, mechanism of action and efficacy claims and minimized risks. DDMAC demanded that the company pull the ad. Christine Poon, vice chairman of the board of directors...
US launch of Dysport([R]) on track PARIS -- Regulatory News: Ipsen (Paris:IPN) today announced that the U.S. Food and Drug Administration FDA provided notification that the Prescription Drug User Fee Act PDUFA action date for Dysport([R]) botulinum toxin of type A Biologics License Application BLA for...
NEW DELHI AFP — Shares of Indian generics giant Ranbaxy shares slid 11 percent Tuesday on reports Canada was looking into the safety of the company's drugs as well as on concerns about its revenue outlook. Ranbaxy shares have been under pressure since the US Food and Drug...
The Food and Drug Administration's (FDA's) Food Protection Plan Progress Report, released on July 2, 2008, in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in...
MethylGene Inc. (TSX: MYG) today announced that as a result of the internal voluntary suspension of enrollment of new patients into clinical trials evaluating MGCD0103, MethylGene and its development partner, Celgene Corporation, have been informed by the U.S. Food and Drug Administration FDA that the agency concurs with the action...
GAITHERSBURG, Md. -- Ore Pharmaceuticals Inc. (NASDAQ: ORXE) today reported financial results for the second quarter ended June 30, 2008. Strategic Update and Quarterly Highlights During the second quarter of 2008, Ore Pharmaceuticals took further actions to advance its commercial drug development activities: *...
The Food and Drug Administration has begun a multiyear hiring initiative and plans to fill more than 1,300 positions within the next several months--nearly triple the number hired during the period spanning 2005 to 2007, the FDA said. The agency said it plans to hire hundreds of individuals with science...
Updating the Food and Drug Administration’s information systems is one of the top priorities of the agency, FDA Commissioner Andrew von Eschenbach, M.D., recently told Congress. He spoke April 22 before the House Energy and Commerce subcommittee on oversight and investigations, which is studying FDA actions to improve the safety...
The Food and Drug Administration has lifted its suspension of Colorado Springs-based Coast Independent Review Board, a disciplinary action that resulted from allegations that Coast violated federal rules intended to protect patients in medical research. Because of the suspension, Coast founder Darren McDaniel has resigned as...
After being pummeled for weeks on Capitol Hill over the president's budget, FDA Commissioner Andrew von Eschenbach, M.D., has written Congress that the agency needs an immediate infusion of $275 million to ensure that imported foods, drugs and medical devices are safe, "The New York Times" reported May 14. ...
Articles 2008-05-20
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