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Home » Authorized Generic Reports to Become Mandatory
Authorized Generic Reports to Become Mandatory
NDA holders will be required to submit information on their authorized generic drugs in annual reports to the FDA under a final rule that takes effect Jan. 25, 2010. The rule helps implement the FDA Amendments Act of 2007, which requires that the FDA publish a list of all authorized generic drugs included in an annual report since 1999, the FDA says in a statement. The agency is required to update the list quarterly.
Drug Industry Daily
Drug Industry Daily
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