Remanufacturing Medical Devices: Your FDA Compliance Checklist
Get clear on FDA guidance for remanufacturing medical devices, including compliance steps, labeling tips, and what the new rules mean for your business.
Regulation
November 14, 2024
Regulation
FDA Transition Plan: A Practical Guide for Manufacturers
Learn how to create a Transition Plan for medical devices affected by FDA enforcement policies during the COVID-19 public health emergency.
Drug's Approval
FDA Approves First Gene Therapy for Treatment of Aromatic L-amino Acid Decarboxylase Deficiency
The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment