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Change Control Pitfalls: Legal and Regulatory Risks in FDA-Regulated Industries

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Article | July 15, 2025

FDA Signals Interest in Defining Ultraprocessed Foods

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Article | July 10, 2025

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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Article | July 01, 2025

FDA Finalizes Cybersecurity Premarket Guidance: What It Means for Medical Device Makers

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Article | June 26, 2025

What to Do When FDA Detains Your Shipment

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Article | June 23, 2025

Event Recap – Saison-al Session Panel Discussion

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Article | June 19, 2025

Helping Clients Close the Right Deals—The Right Way

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Article | June 17, 2025

Event Recap – Hot or Cold? A Privacy Enforcement Update

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Article | June 12, 2025

The Importance of a Clinical Trial Strategy

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Article | June 10, 2025

Event Recap – Pour Decisions: Lessons in Healthcare Fraud and Liability Cases

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Article | June 05, 2025

New DOJ Rule Restricts Deidentified Data Transfer

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Article | June 03, 2025

Event Recap – Tapping into FDA: Regulatory Hot Topics

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Article | May 29, 2025

Event Recap – What's Brewing in Compliance?

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Article | May 27, 2025

FDA’s Latest Untitled Letter: An Enforcement Tell?

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Article | May 22, 2025

Event Recap – What's On File Could Be On Trial: Mastering Document Risk Part II

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Article | May 19, 2025

FDA Goes All In on AI: What It Means for Your Submissions

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Article | May 15, 2025

Event Recap – AI & HIPAA: Legal Challenges and Solutions for Medtech

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Article | May 13, 2025

Staying Prepared Amid FDA Changes

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Article | May 08, 2025

Event Recap – What's On File Could Be On Trial: Mastering Document Risk

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Article | May 06, 2025

Are FDA Review Timelines Slipping? What Companies Need to Know

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Article | May 01, 2025

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

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Article | April 28, 2025

Event Recap – Disciplined Innovation: From Concept to Market in Medical Technology

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Article | April 24, 2025

State Food Additive Bans Signal a Shift in Regulatory Priorities

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Article | April 22, 2025

Event Recap: Ski-LE – An In Person FDA and Compliance Legal - Regulatory Update

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