pexels edward jenner 4031690 scaled 600 by 900

ICH M13B Webinar

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" that was endorsed by...

read more

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.

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...

read more

State of the Science for Bioaccumulation

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...

read more

Confer With – 707691 – 08/01/2025

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,...

read more