Home » US FDA Responds to Concerns About Authorized Generics Reporting
US FDA Responds to Concerns About Authorized Generics Reporting
March 17, 2009
The U.S. Food and Drug Administration (FDA) withdrew its direct final rule requiring drugmakers to report information on authorized generics in new drug application (NDA) annual reports, delaying implementation of part of the FDA Amendments Act (FDAAA) and giving companies more time to prepare for the rule.
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