by Pill Pals Customer Service | Oct 10, 2025 | News
Who Is the Audience for This Website?FDA’s generic drug-specific labeling resources are primarily directed to industry staff who develop generic drug labeling. For more information about:Generic Drug LabelingGeneric drug labeling [labeling under an abbreviated new...
by Pill Pals Customer Service | Oct 10, 2025 | News
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,...
by Pill Pals Customer Service | Oct 10, 2025 | News
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...
by Pill Pals Customer Service | Oct 10, 2025 | News
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...
by Pill Pals Customer Service | Oct 10, 2025 | News
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...
by Pill Pals Customer Service | Oct 10, 2025 | News
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...
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