FDA Urges Strong Quality Pacts For Drugmakers, Contractors

Law360, New York (May 28, 2013, 4:45 PM EDT) -- Wading into an area that has been the subject of recent enforcement, the U.S. Food and Drug Administration on Friday explained its quality-control expectations for pharmaceutical companies and their contractors, hammering home the point that precise written agreements aid compliance with current good manufacturing practices.

In a 15-page guidance document, the FDA devoted considerable ink to impressing upon drugmakers and contract manufacturers the need for quality agreements that go into minute detail about the parties’ responsibilities, equipment and facilities to be used, management of raw materials,...
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