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Get Ready for the Investigators

InHouseOps

JULY 2, 2021

To understand the key shifts, particularly during the COVID-19 pandemic, Nuix engaged Ari Kaplan Advisors to study the best practices for interacting with an array of financial and competition regulators around the world, as well as their preferred technology protocols, primary enforcement strategies, and data sharing preferences.

Technology

Technology Education Malfeasance eDiscovery

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

MAY 8, 2023

Once FDA has cleared or approved a PCCP, that statute states that a supplemental application “shall not be required” to make a change consistent with such PCCP. Once authorized, a PCCP is considered a technological characteristic of the authorized device.

Drafting

Drafting Manufacturing Data Management Technology

Paralegal Brief

Get Ready for the Investigators

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

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