About
Christina Kuhn provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.
FDA Releases Discussion Paper on AI in the Drug and Biological Product Development Process
FDA Releases Draft Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations

3 Takeaways Digital Health Innovators Should Be Watching in the PREVENT Pandemics Act
5 Digital Health Issues to Watch at FDA in 2022
FDA Releases AI Action Plan
FDA Issues Final Guidance on Multiple Function Digital Health Software and Other Devices

AI/IoT Update: The Potential Benefits of Digital Health Technology in Managing COVID-19
COVID-19: FDA Regulatory Considerations for Digital Health Solutions
FDA Issues Updated Guidance on the Regulation of Digital Health Technologies
About
Christina Kuhn provides pharmaceutical and medical device companies advice on a variety of federal and state regulatory matters.