FDA Regulatory

Consumer Products in Focus: New FTC and FDA Guidances Address the Marketing of Health Products (January 10, 2023)
New FDA Reform Legislation: Congress Gifts a “FDORA” for the Holidays (January 9, 2023)
Joshua Oyster and Beth Weinman Present at Food and Drug Law Institute Enforcement Conference (December 9, 2022)
Podcast - Non-binding Guidance: The Regulatory Landscape for Drug Compounding—10 Years After the NECC Outbreak (December 5, 2022)
Podcast - Non-binding Guidance: Key Takeaways from FDA’s Final Guidance on Clinical Decision Support Software (November 21, 2022)
White House Issues Executive Order Outlining Key Points of the Transatlantic Data Privacy Framework (October 13, 2022)

Non-binding Guidance: Continued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market Access

Is Your Clinical Decision Support Software a Medical Device? Final Guidance Details FDA’s Latest Thinking (October 3, 2022)
New Executive Order Formalizes Expanded CFIUS Purview (September 20, 2022)
Harmonizing the Common Rule and U.S. Food and Drug Administration Human Subjects Research Regulations (September 13, 2022)
Podcast - Non-binding Guidance: Real-World Evidence in Drug Development (March 30, 2022)
In Law360, Life Sciences Attorneys Examine FDA’s Proposed Medical Device Rule (March 24, 2022)
FDA Proposed Rule Would Harmonize U.S. Quality System Requirements for Medical Devices with International Standard (March 8, 2022)
Washington Attorneys Expect Aggressive Enforcement Related To FDA Regulated Medical Products in 2022 (February 15, 2022)
DOJ Increases Focus on Clinical Trial Fraud (February 1, 2022)
2021 Enforcement Review: FDA-Regulated Medical Products (January 31, 2022)
Contemplating a Post-COVID Return to “Normal Operations”: FDA’s Transition Plans for Devices Marketed Under Emergency Use Authorizations and Enforcement Policies (January 13, 2022)
Podcast: Non-binding Guidance: Recent Developments in FDA Inspection Policy and Implications for Drug and Device Manufacturers (January 6, 2022)
In Law360, Life Sciences Attorneys Examine FDA’s Transition Plans for Medical Devices Under Emergency Use Authorizations and Enforcement Policies (January 20, 2022)
Medtech Insight Discusses False Claims Act Focused Panel Moderated by Beth Weinman at FDLI Conference (December 16, 2021)
HHS Reverses Course on LDTs: COVID-19 LDTs Again Require FDA Premarket Review (December 3, 2021)
Podcast: Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule (November 8, 2021)
In Food and Drug Law Journal, Jonathan Iwry Examines FDA Emergency Use Authorization Historical Lessons (October 25, 2021)
In Food and Drug Law Journal, Attorneys Analyze COVID-19 Impact on American Medical Product Supply Chain and Initiatives to Strengthen Supply Chain Security (October 19, 2021)
Podcast: Non-binding Guidance: FDA’s Intended Use Final Rule (September 21, 2021)
Podcast: Non-binding Guidance: COVID-19 Vaccine Mandate Litigation (July 29, 2021)
Podcast: Non-binding Guidance: The Defense Production Act and the COVID-19 Pandemic (May 27, 2021)
Attorneys Examine FDA Enforcement Implications of U.S. Supreme Court Decision on Restitution and Disgorgement (May 6, 2021)
New Laws Narrow the Scope of Market Exclusivity and Seek to Increase Awareness of Biosimilars (April 30, 2021)
Event: Navigating Life Sciences M&A Under the Biden Administration | Drug Pricing & Antitrust Considerations (March 25, 2021)
Podcast: Non-binding Guidance: FDA Regulatory Developments in AI and Machine Learning (March 4, 2021)
FDA Publishes Action Plan for Oversight of Artificial Intelligence/Machine Learning-Based Medical Software (February 9, 2021)
2020 Enforcement Review: FDA-Regulated Medical Products and Food Safety (January 28, 2021)
The 2020 Election and Life Sciences (December 1, 2020)
In Law360, Attorneys Examine Change in FDA's Review Priorities for COVID-19 Lab-Developed Tests (October 22, 2020)
In Bloomberg Law, Greg Levine Evaluates FDA Plans for Permanent COVID-19 Test Authorization (October 20, 2020)

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