Article | October 01, 2026 You Don’t Know What You’ve Got ’til It’s Gone: Regulatory Strategy for a Strained FDA Read More
Article | September 17, 2026 FDA Seeks Input on Regulatory Framework for Generative AI-Enabled Medical Devices Read More
Article | September 08, 2026 Can You Say It in 30 Seconds? Short-Form Video and the Limits of Promotional Compliance Read More
Article | August 06, 2026 AI Clinical Decision Support Software: The New Regulatory Reality for Digital Health and Life Sciences, Pt 2 Read More
Article | August 04, 2026 AI Clinical Decision Support Software: The New Regulatory Reality for Digital Health and Life Sciences, Pt 1 Read More
Article | July 30, 2026 FDA Finalizes Risk-Based Framework for Human Factors Information in Medical Device Submissions Read More
Article | July 22, 2026 FDA's Anticipated Proposed Rulemaking for Direct-to-Consumer Advertising Read More
Article | July 07, 2026 CMS Launches New Office Focused on AI, Interoperability & Digital Health Read More
Article | June 18, 2026 FDA's New One-Day Inspection Pilot: More Efficient Oversight or More Questions Than Answers? Read More
Article | June 16, 2026 FDA’s Drug Repurposing Initiative Signals a Shift in Regulatory Strategy Read More
Article | May 01, 2026 Mississippi Establishes New Medical Device Establishment License and Expands Definition of “Device” Read More
Article | March 24, 2026 OPDP’s 2026 Untitled Letters: Early Enforcement Trends in Prescription Drug Promotion Read More
Article | August 22, 2023 Panel Session Recap: Navigating the M&A Waters of FDA-Regulated Companies Read More
Article | August 07, 2023 FDA Regulatory, Compliance, and Privacy Due Diligence — Finding Your Goldilocks Zone Read More
Article | June 21, 2023 Beyond Paperwork: Assessing the Effectiveness of a Compliance Program Read More