Gunawardhana Comments on Artificial Intelligence in FDA Week

FDA Week interviewed Shook Of Counsel Sonali Gunawardhana for the article, “Harvard Fellowship Program will Help FDA Hone AI as Regulatory Tool.” 

Gunawardhana said that artificial intelligence (AI) “could be used to analyze amounts of data that are too large or complicated for a single human to handle,” according to the article. “For example, the analysis of a medical product's effectiveness may be confounded by a wide range of factors such as the patient's age, weight or local environment."

"I'm excited about how AI will be used in this context, simply because there is so much data that has already been gathered that can assist patients [to] better manage their health," she said.