Raw Bistro Pet Fare Voluntarily Recalls Frozen Beef Entrée Because of Possible Salmonella Health Risk

by Pill Pals Customer Service | Oct 10, 2025 | News

Summary Company Announcement Date: October 10, 2025 FDA Publish Date: October 10, 2025 Product Type: Animal & VeterinaryFood & Beverages Pet Food Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness –...

FDA Approves Labeling Changes that Include a Boxed Warning for Immune

by Pill Pals Customer Service | Oct 10, 2025 | News

AUDIENCE: Patient, Health Care Professional, Pharmacy, GastroenterologyISSUE: The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI. Reports were received from clinical trials and...

Generic Drugs – Specific Labeling Resources

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...

GDUFA IV Reauthorization

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,...

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...