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16
Apr
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March 2020 Approval Actions, CRLs and Receipts and Update on Feb Metrics

By    Apr 16, 2020    ANDAs FDA Generics Metrics

Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics.  Let’s start with the new March data. OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total […]

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08
Jan
OGD Updates Additional Metrics In March Stats Image

OGD Updates November 2019 Metrics

By    Jan 08, 2020    ANDAs FDA Generics Metrics Regulatory Affairs

Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs. There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen […]

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