Complex Generic Mid-Cycle Meetings: US FDA Suggests Taking The Date Offered

US FDA offers best practices and tips to ensure successful meetings, although few have been conducted so far.

Woman uses an inhaler during an asthma attack, close-up — The US FDA does not want complex generic sponsors to delay mid-cycle meetings if possible, because it could render them less productive.

The US Food and Drug Administration has little experience conducting mid-assessment cycle meetings for generic drug sponsors, but already cautions that trying to reschedule may not improve the outcome.

Mid-cycle meetings with agency officials are available for complex generic drug sponsors to discuss issues that have been found in an abbreviated new drug application while the assessment is ongoing....

Complex Generic Mid-Cycle Meetings: US FDA Suggests Taking The Date Offered

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