FDA

Download the FDAs Action Plan on “Artificial Intelligence/Machine Learning (AI/ML)- Software as a Medical Device (SaMD)”

01/26/2021

The FDA has released a new Action Plan on Artificial Intelligence/Machine Learning (AI/ML)- Software as a Medical Device (SaMD). You can download it below by clicking the button! Download The Action Plan

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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

05/26/2019

In March of 2019 the FDA released this statement regarding the value of Expanded Access Programs and the FDA’s encouragement of Sponsors to consider providing them as options for Patient Populations. A few interesting statements worth highlighting in the statement: “Since 2010, drug sponsors and manufacturers have given the opportunity of such access to more…

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