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King & Spalding

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

King & Spalding on

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

Epstein Becker & Green

Unpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents

Epstein Becker & Green on

This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more

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