Article | January 14, 2025

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

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Article | January 07, 2025

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

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Article | December 20, 2024

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

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Article | December 19, 2024

Exploring the Loper Decision: Impacts on FDA-Regulated Transactions

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Article | December 18, 2024

Revealing Risk: Cybersecurity Due Diligence

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Article | December 17, 2024

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

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Article | December 15, 2024

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

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Article | December 05, 2024

FDA Tightens Food Chemical Safety Rules

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Article | December 03, 2024

LDT Compliance: Countdown to May 2025

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Article | November 21, 2024

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

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Article | November 20, 2024

FDA Launches New Human Foods Program

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Article | November 19, 2024

Best Practices for Responding to an FDA Form 483

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