Category Archives: FDA

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 […]
Also posted in Biotech, Corporate Responsibility, Emerging Markets, Europe, Global, Guest Blog, Market Access, pricing, Strategy | Tagged , , , , , , | 3 Comments

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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Love Potion #9: The Hypoactive Sexual Desire Disorder Pipeline

New products in development for women distressed by a lack of sexual desire and satisfying sexual experiences are causing a stir, but not for the reasons one might expect.   Do women have less of a right than men to combat sexual disorders with pills? That’s the question eight national and international women’s advocacy groups […]
Also posted in healthcare, leadership, Market Access, Patient Communication, R&D, Regulatory, Safety, Strategy | Tagged , , , , , , , , , | 1 Comment
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