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Healthcare Public Comment New Guidance

McDermott Will & Schulte

HRSA issues 340B rebate model pilot program guidance, requests comments

The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate...more

McDermott Will & Schulte

FDA Issues Good Machine Learning Practice Guiding Principles

On October 27, 2021, pursuant to the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan (Action Plan), the US Food and Drug Administration (FDA) released its Good Machine Learning...more

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