- Event: Beth Weinman Moderates International Bar Association World Life Sciences Conference Roundtable (June 2, 2023)
- FDA Guidance Clarifies Approach to Decentralized Clinical Trials (May 5, 2023)
- Getting Smarter: FDA Publishes Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning (AI/ML) Devices
(May 2, 2023)
- Beth Weinman Presents on Considerations in Shift Toward U.S. Pharmaceutical Manufacturing (March 30, 2023)
- Podcast: U.S. Life Sciences Outlook 2023 (Part IV): Additional Insights on Expected Developments (March 1, 2023)
- Podcast: U.S. Life Sciences Outlook 2023 (Part III): Agency Litigation Challenges (February 27, 2023)
- Podcast: U.S. Life Sciences Outlook 2023 (Part II): Anticipated Agency Policy Developments (February 23, 2023)
- Podcast: U.S. Life Sciences Regulatory Outlook 2023 (Part I): 2022 Trends Expected to Continue Into 2023 (February 21, 2023)
- The End of an Era: How Will Terminating the COVID-19 Public Health Emergency Affect Life Sciences Companies? (February 8, 2023)
- 2022 Enforcement Review for FDA-Regulated Products: Back to Basics (February 2, 2023)
- 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)
-
Non-binding Guidance: Continued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market Access (October 13, 2022)
- 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, 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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