Along With All NDAs Submitted To US FDA In FY2023, Costs For OTC Switch Proposals Increase
Agency publishes Prescription Drug User Fee Act rates for FY2023, the first of five covered in reauthorization of program Congress approved on 30 September as legislation added to a continuing resolution to fund federal agencies through 16 December.
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Submitting other OTC monograph program communications through CDER's NextGen Portal, including proposals to add formulations or indications to a monograph, will have to wait.
With current user fee package as well all federal spending programs for FY2022 expiring on 30 September, House and Senate committee leaders reach agreement on FDA user fee reauthorization included in a continuing resolution to extend federal spending at current levels through 16 December.
Perrigo's HRA Pharma submits to FDA on 11 July an NDA by for OTC 0.075-mg norgestrel, branded Opill, The same formulation previously was available Rx 30 years.