GDUFA IV Reauthorization
In September 2022, the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) was enacted, which included the third reauthorization of the Generic Drug User Fee Amendments (GDUFA). The current legislative authority for GDUFA III expires in September 2027. At that time,...GDUFA III Reauthorization
Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of...Premarket Approvals and HD Exemptions with Supporting Documents
This list includes applications for which we have approval documents available, and reflects the information as of the approval date. It is not updated with regard to applicant or application status changes. Information is arranged in alphabetical order by the name of...ADSTILADRIN
STN: BLA 125700Proper Name: nadofaragene firadenovec-vncgTradename: ADSTILADRINManufacturer: Ferring Pharmaceuticals A/SIndication: ADSTILADRIN is indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-Muscle...Automated Impella Controller Correction due to Cybersecurity Issue
This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without...All Drug Purchases Are
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