Tag Archives: FDA

Ranbaxy Suspends Shipments, Addresses Quality and Integrity Problems

Following the U.S. ban on all imports from Ranbaxy’s Toansa, India, facility, the drug maker has voluntarily suspended all shipments of bulk drugs from its manufacturing facilities both at Toansa and Dewas, in order to reassess quality controls at the plants.
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Risk-Based Monitoring: From the Road Less Traveled to Productivity Superhighway

Risk-Based Monitoring:  From the Road Less Traveled to Productivity Superhighway By:  Mukhtar Ahmed, global vice president, life sciences strategy, Oracle Health Sciences The latest news on the growing cost of conducting clinical trials is becoming a major concern for company sponsors and trial co-operative groups.  Clinical trials cost 60% more today than they did just […]
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Drug Shortages Continue to Plague Health Care System

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name. The Food and Drug Administration is doing a better job of identifying potential shortage situations and implementing relief strategies, but many supply problems continue to limit treatment options […]
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FDA Guidances, OIG Investigations to Shape Drug Marketing, Research

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media. Priority topics:  presenting risk and benefit information in limited space; correcting independent/third party misinformation about a drug or medical device; and appropriate use of links, according to the agenda for the Center […]
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FDA Extends Oversight of Large Compounders

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance. The agency is pleased that 14 outsourcers registered through mid-January. The number is small, considering that an estimated 3000 compounding pharmacies make […]
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