FDA’s Updated Approach to the 510(k) Premarket Notification Process for Medical Devices
Enhancing Safety and Efficiency
Enhancing Safety and Efficiency
Toxic Yellow Oleander in Certain Supplements Receives Updated FDA Warning
New Fiscal Year 2024 Rates and What You Need to Know
Implications for Food Industry and Businesses
FDA Updates Draft Guidance for Medical Device Submissions: The Q-Submission Program
FDA Issues Final Guidance on Updated Procedures and Timeframes
FDA Proposes Modifications to Medical Device User Fee Small Business Qualification and Certification
The dreaded “Red List” and “Black List” (even the colors and short-form names spark fear!) commonly refer to FDA’s enforcement tool, “Import Alert”, an FDA-directive
FDA Makes Changes to Device GMPs to Align More Closely with International Consensus Standards.
FDA Showcases New Regulation Portal for Food + Cosmetics Program