Article | August 06, 2025

Cybersecurity and the FCA: Illumina Signals "No Breach" Enforcement Risks

Read More

Article | July 31, 2025

Why Every Manufacturer Needs a Robust Information Security Program

Read More

Article | July 22, 2025

The Value of MDUFA

Read More

Article | July 17, 2025

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

Read More

Article | July 15, 2025

FDA Signals Interest in Defining Ultraprocessed Foods

Read More

Article | July 10, 2025

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

Read More

Article | July 01, 2025

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

Read More

Article | June 26, 2025

What to Do When FDA Detains Your Shipment

Read More

Article | June 23, 2025

Event Recap – Saison-al Session Panel Discussion

Read More

Article | June 19, 2025

Helping Clients Close the Right Deals—The Right Way

Read More

Article | June 17, 2025

Event Recap – Hot or Cold? A Privacy Enforcement Update

Read More

Article | June 12, 2025

The Importance of a Clinical Trial Strategy

Read More

Article | June 10, 2025

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

Read More

Article | June 05, 2025

New DOJ Rule Restricts Deidentified Data Transfer

Read More

Article | June 03, 2025

Event Recap – Tapping into FDA: Regulatory Hot Topics

Read More

Article | May 29, 2025

Event Recap – What's Brewing in Compliance?

Read More

Article | May 27, 2025

FDA’s Latest Untitled Letter: An Enforcement Tell?

Read More

Article | May 22, 2025

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

Read More

Article | May 19, 2025

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

Read More

Article | May 15, 2025

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

Read More

Article | May 13, 2025

Staying Prepared Amid FDA Changes

Read More

Article | May 08, 2025

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

Read More

Article | May 06, 2025

Are FDA Review Timelines Slipping? What Companies Need to Know

Read More

Article | May 01, 2025

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

Read More