GDUFA III Reauthorization

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...

Premarket Approvals and HD Exemptions with Supporting Documents

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...

ADSTILADRIN

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...

Automated Impella Controller Correction due to Cybersecurity Issue

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...

Foodynamics Recalls Raw Dog Barkery, BellePepper Cats, and Kanu Pets Brand Freeze-Dried Pet Treats Because Of Possible Salmonella Contamination

by Pill Pals Customer Service | Oct 9, 2025 | News

Summary Company Announcement Date: October 09, 2025 FDA Publish Date: October 09, 2025 Product Type: Animal & VeterinaryFood & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Salmonella Company...

Sprouts Farmers Market is Recalling Smoked Mozzarella Pasta Salad Because of Possible Health Risk

by Pill Pals Customer Service | Oct 9, 2025 | News

Summary Company Announcement Date: October 08, 2025 FDA Publish Date: October 09, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Listeria monocytogenes Company Name: Sprouts...