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As medical device software and other technology continue to advance at a rapid pace, the FDA’s regulatory policies and processes are being forced to evolve to keep pace with innovation. View

Your international drug and device business is at a crossroads known as Brexit — the withdrawal of the United Kingdom (UK) from the European Union (EU). What can you expect? View

The rules on device quality auditing are changing. There’s a new ISO 19011:2018 out with a new focus on risk management. View

Will de novo work for you? Don’t miss out on your chance to get a better insight into de novo’s requirements and timelines. View

From Washington (the FDA, the FTC) to the states (attorneys general) to City Hall, dozens of agencies take an interest in the way you advertise and market your products. Take a crash course in dealing with this panoply of enforcers. View

It’s important for everyone involved in device design, cybersecurity and regulation to understand these issues. Dan O’Leary, simplifies the knotty area of FDA and international device regulation. View

You need to take your supplier quality metrics to the next level. The “Second Data Tier” — used in Compliance and Productivity Metrics — allows for stronger problem prevention and risk management of both internal and supplier processes. View

It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View

What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View

What devicemakers know is that MDR reporting is slated to change, with the old coding system going obsolete and new challenges arising to completion of Form 3500A. What many devicemakers still don’t know — but need to — is that the FDA is ready to assist you, with a free downloadable tool known as eSubmitter. View

Order your copy of Top Trends in Drug and Device Advertising and Promotion: Enforcement Priorities for the FDA and FTC and know how to handle hot spots in advertising and promotion while avoiding warning letters and other enforcement actions. View

The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View