FDA Explains How It Counts To 30 Months
Agency rejects Sandoz’s assertion that the 30-month period for securing ANDA tentative approval under the MMA’s forfeiture provisions begins to run on the date an application is submitted.
Agency rejects Sandoz’s assertion that the 30-month period for securing ANDA tentative approval under the MMA’s forfeiture provisions begins to run on the date an application is submitted.