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Drug Product Recalls In 2010: Categorized By Problem Area

This article was originally published in The Gold Sheet

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FDA Sending More Drug GMP Warning Letters to Foreign Sites

FDA warning letters are up at foreign sites and down at domestic sites as agency ramps up presence abroad. Inadequate OOS investigations and faulty testing of drug components were top violations; contamination was a common issue; firms cited included Novartis, Mylan, Smithkline Beecham, Lonza and Noven.

Use QbD to Get Through Rough Patch, FDA Tells Transdermal Makers

FDA officials say that there are “scientific gaps” in how transdermal patches are developed, manufactured and regulated, and urged manufacturers to adopt quality- by-design methods to help bridge these gaps and to better ensure product quality and safety.

Use QbD to Get Through Rough Patch, FDA Tells Transdermal Makers

FDA officials say that there are “scientific gaps” in how transdermal patches are developed, manufactured and regulated, and urged manufacturers to adopt quality- by-design methods to help bridge these gaps and to better ensure product quality and safety.

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