Estimated FDA User Fee Review Goals For Pending NDAs/BLAs
This article was originally published in Pharmaceutical Approvals Monthly
Estimated user fee goals for FDA action on publicly disclosed NDAs, BLAs and efficacy supplements are calculated based on the date of receipt and assignment to standard or priority review. Resubmissions with significant new data or analyses have a 6-month goal. FDA may extend review goals.
You may also be interested in...
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Judge ordering permanent injunction against Confidence USA on a complaint filed in 2019 questioned FDA's calculations for requiring the firm to recall and destroy all products it had distributed since February 2018.
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.