ICH M13B Webinar

by Pill Pals Customer Service | Aug 12, 2025 | News

On This Page Date: September 11, 2025 Time: 12:00 p.m. – 2:00 p.m. ET This webinar will provide an in-depth look at the draft ICH M13B guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver”...

Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device.

by Pill Pals Customer Service | Aug 12, 2025 | News

Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns Company Name: Max Mobility, LLC. Brand Name: Product...

State of the Science for Bioaccumulation

by Pill Pals Customer Service | Aug 12, 2025 | News

On This Page The Eco-NAMS webinar series is co-organized by the U.S. Food and Drug Administration, U.S. Environmental Protection Agency, European Medicines Agency, Health and Environmental Sciences Institute, National Institute for Environmental Studies (Japan), and...

Confer With – 707691 – 08/01/2025

by Pill Pals Customer Service | Aug 12, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Serge Milbank Confer With 81 Rivington StLondonEC2A 3AYUnited Kingdom getintouch@conferwith.io Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTERAugust 1,...

Increased Incidence of Candida auris Colonization in Early COVID-19 Pandemic, Orange County, California, USA

by Pill Pals Customer Service | Aug 12, 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: Orange County Health Care Agency, Santa Ana, California, USA (A.H. Dratch,...

Kalani AB dba Kalani Sunwear – 710998

by Pill Pals Customer Service | Aug 12, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Anna Xavier Kalani AB dba Kalani Sunwear Brahegatan 28114 37 StockholmSweden info@kalani.se Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTERAugust 6, 2025RE:...

Vacation Inc. – 706039 – 08/06/2025

by Pill Pals Customer Service | Aug 12, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name James Dakota Green Vacation Inc. 936 SW 1st Ave #888Miami, FL 33130United States vacation@vacation.inc Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTERAugust...

Supergoop! – 711018 – 08/06/2025

by Pill Pals Customer Service | Aug 12, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Lisa Sequino Supergoop! 200 East Grayson Suite #110San Antonio, TX 78215United States hello@supergoop.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING...

Filter Recall: Draeger Removes SafeStar and TwinStar Filters

by Pill Pals Customer Service | Aug 12, 2025 | News

This recall involves removing certain devices 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.Affected ProductProduct NameModel NumberUDI-DILot...