Changes for Manufacturing, Trials, Generics to Affect Drugmakers in 2012

Washington Drug Letter
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The FDA made good last year on promises to tighten up loose links in the global drug supply chain while addressing criticism that agency decisionmaking is unduly opaque. 2011 also saw changes to trial requirements and big steps toward user fee agreements for generic drugs and biosimilars. WDL editors offer this recap of the most important events of the year so readers can ensure their programs are ready to succeed in 2012.

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