Category Archives: FDA

Track-and-Trace Not Enough to Halt Drug Counterfeiters

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight. Criminals are expanding from “lifestyle” drugs to widely used anti-cholesterol and cancer medicines, attracted by huge profits and low risks […]
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New Fees Made FDA Worse for Generic Drug Approvals, Says GPhA Chairman

‘Actions’ don’t speak louder than words in dealing with FDA’s backlog of generic drug applications, says newly-elected GPhA Board Chairman Craig Wheeler. When the Generic Drug User Fee Act (GDUFA) was signed into law on July 7, 2012, its primary intent was to provide FDA with the additional resources necessary to expedite the review process […]
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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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Bringing New Rx Drugs to Market in 2014

by Tom Norton I did something today that I haven’t done in years: I checked out the US pharmaceutical R&D spend versus the rest of the world. Having known since the 80’s that the US owned this space, a quick look at the latest R&D figures confirmed my decades old understanding of the industry’s worldwide […]
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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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