Article | January 14, 2025

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

Read More

Article | January 07, 2025

Breaking the Ice: FDA-Focused Firm Leader Sees Benefits in AI

Read More

Article | December 20, 2024

Due Diligence Decoded: Insights from In-House Counsel at Boston Program

Read More

Article | December 19, 2024

Exploring the Loper Decision: Impacts on FDA-Regulated Transactions

Read More

Article | December 18, 2024

Revealing Risk: Cybersecurity Due Diligence

Read More

Article | December 17, 2024

Honesty is the Best Policy: Navigating the DOJ’s M&A Safe Harbor

Read More

Article | December 15, 2024

Navigating the Complex Regulatory Landscape for AI/ML-Enabled Medical Devices

Read More

Article | December 05, 2024

FDA Tightens Food Chemical Safety Rules

Read More

Article | December 03, 2024

LDT Compliance: Countdown to May 2025

Read More

Article | November 21, 2024

Post-Election FDA Landscape: Will There Be Regulatory Shifts Ahead in 2025 and Beyond?

Read More

Article | November 20, 2024

FDA Launches New Human Foods Program

Read More

Article | November 19, 2024

Best Practices for Responding to an FDA Form 483

Read More

Article | November 14, 2024

Surviving FDA Inspections: Proactive Preparation is Key

Read More

Article | November 12, 2024

Protecting Your Business During a Search Warrant

Read More

Article | November 08, 2024

Responding to CIDs & Government Inquiries: A Practical Guide

Read More

Article | October 30, 2024

Navigating Government Investigations: A Guide for FDA-Regulated Companies

Read More

Article | October 29, 2024

Responding to Letters from FDA

Read More

Article | October 23, 2024

OIG’s Perspective on Discount and Refund Programs

Read More

Article | October 21, 2024

What the DOJ Looks For: Key Insights into Evaluating Your Compliance Program

Read More

Article | October 15, 2024

FDA Compliance: Conducting a Recall

Read More

Article | October 10, 2024

Gardner Law Launches Litigation Practice with Renowned Attorney David Graham

Read More

Article | October 01, 2024

Latest Untitled Letter from FDA’s OPDP Underscores Need for Careful Approach to Advertising

Read More

Article | September 25, 2024

Hiring Conflicts Result in FCA Violations

Read More

Article | September 18, 2024

Privacy Summer School – “Back to School” Recap

Read More