FDA to Hold Public Meeting on Proposed Medical Device Review Recommendations
Key Takeaway: The FDA announced a public meeting and request for comments on proposed Medical Device User Fee Amendments (MDUFA )recommendations for fiscal years 2028-2032, which would govern medical device...
FDA Emphasizes Use of Real-World Evidence for Medical Device Makers
The U.S. Food and Drug Administration (FDA) has increasingly emphasized the use of real-world evidence (RWE) to support regulatory decision-making for medical devices. As medical technologies evolve and data sources...
Amendments to Mexico’s Federal Law for Protection of Industrial Property Inform More Flexible International IP Strategy for Biotech Companies
Key Takeaway: Amendments to Mexico’s Federal Law for Protection of Industrial Property align more with U.S. Patent and Trademark Office standards for restoring priority and application revival, increasing international patent...
Subscribe for News and Updates