Benjamin England, FDAImports.com Founder and CEO recently presented a webinar with FDANews, entitled “Thinking Ahead of FDA: Preventive care tips for your FDA import compliance program.”
Mr. England said, “Up to now, FDA has been mostly reactionary in its enforcement on these issues of safety for drugs and medical devices, but that’s all about to change. These new regulations give FDA the authority to start working preventively – and FDA clearly wants to. Companies need to be proactively implementing and continually examining their compliance programs if they want to stay ahead of the curve.”
The webinar was structured for importers and distributors in the US, discussing FDA’s current and future approaches to enforcement and how these changes will affect import compliance. Mr. England presented a clear, insightful explanation of FDA’s stance on imports and its method of addressing issues, as well as a brief analysis of useful ways to approach FDA to prevent or resolve these issues. He then explained the upcoming changes to FDA’s approach – primarily focusing on the Food and Drug Administration Safety and Innovation Act (FDASIA), the Drug Quality and Security Act (DQSA), and the recent regulation requiring Unique Device Identifiers (UDIs) for all medical devices.
The webinar allowed attendees to learn more about the tools and methods FDA uses in its enforcement of these new regulations, as well as how to address those specific approaches in their own regulatory compliance programs.
Benjamin England is a 17-year veteran of the FDA. His last position held was Regulatory Counsel (Attorney) to FDA’s Associate Commissioner for Regulatory Affairs.
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