GMP Warnings Split Between Brand, Generic Firms; Congress Watches FDA
Executive Summary
The number of prescription drug manufacturing warning letters from FDA remained roughly split between brands and generics during the last year, but brands dominated the citations in early 2008, in contrast to generics' dominance since mid-year, when the House Energy and Commerce Committee launched an investigation into the agency's handling of products produced by Ranbaxy
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FDA's decision to invoke its Application Integrity Policy with Ranbaxy emphasizes the political risks that the generic industry faces as the debate on import safety returns the fore in Congress