Category Archives: R&D

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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Bioscience Research: China to Overtake U.S. by 2020

Bioscience research in China is set to overtake the United States within the next five to ten years, according to data from search engine CiteAb.
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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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180 Diabetes Medicines in Development in the U.S.

America’s biopharmaceutical research companies are currently developing 180 new medicines to help the nearly 400 million people who have diabetes worldwide. These medicines in development, all either in clinical trials or under review by FDA, include 30 for type 1 diabetes, 100 for type 2, and 52 for diabetes-related conditions, according to a new report […]
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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 […]
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