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Electronic Submission Template for Medical Device Q-Subs Guidance

by Pill Pals Customer Service | May 28, 2025 | News

Submit Comments by 07/28/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...

GDUFA IV Public Meeting

by Pill Pals Customer Service | May 27, 2025 | News

On This Page Date: July 11, 2025 Time: 9:00 a.m. – 2:00 p.m. ET The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal...

List of Active RDRC Sites

by Pill Pals Customer Service | May 27, 2025 | News

1Columbia University Medical CenterNew York, New York2Brigham and Women’s HospitalBoston, Massachusetts8University of Kansas Medical CenterKansas City, Kansas10University of PennsylvaniaPhiladelphia, Pennsylvania11University of Virginia Health...

The Coastal Companies Issues Voluntary Recall on Items with Fresh Start Cucumbers Due to the Potential for Salmonella Contamination

by Pill Pals Customer Service | May 27, 2025 | News

Summary Company Announcement Date: May 22, 2025 FDA Publish Date: May 27, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential for Salmonella contamination. Company Name: The Coastal Companies Brand...

Clinical Manifestations, Risk Factors, and Disease Burden of Rickettsiosis, Cambodia, 2007–2020

by Pill Pals Customer Service | May 27, 2025 | News

Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Culmen International, LLC, Alexandria, Virginia, USA (G.C. Kelly, L.K....

Risk of False Positive Lead Test Results with Certain Capillary Blood

by Pill Pals Customer Service | May 27, 2025 | News

Date Issued: April 24, 2025The U.S. Food and Drug Administration (FDA) is alerting health care providers and laboratory staff of reports that falsely elevated (false positive) results have occurred when using ASP Global’s RAM Scientific SAFE-T-FILL Micro Capillary...