Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned – 09/23/2025

B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System

Some Ivenix LVP Primary Administration Sets were assembled with the drip chamber and Luer Lock components in reversed positions, potentially leading to clinical complications

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.

CGMP/Finished Pharmaceuticals/Adulterated

Navitas Organics is voluntarily recalling select lots of its 8oz Organic Chia Seeds due to possible Salmonella contamination. This recall is being conducted as a precautionary measure following a recall initiated by the company’s chia seed supplier.

Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.