ANDA Sponsors Face Tight Controls On Meetings With US FDA After CR Letters
Meetings are intended to help generic sponsors understand deficiencies, but agency won't let them run past 30 minutes.
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Generic submissions were below historical norms in December and modestly higher January, meaning shutdown likely did not create a large pile of pending work.
Kathleen Uhl says applicants can avoid RTRs by conducting quality checks before submission, but sponsors may have difficulty changing their approach because of how fundamental application speed is to their business model.
OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.