On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
5/12/2023
/ Artificial Intelligence ,
Center for Drug Evaluation and Research (CDER) ,
Comment Period ,
Digital Health ,
Food and Drug Administration (FDA) ,
Governance Standards ,
Machine Learning ,
Medical Devices ,
National Evaluation System for Health Technology (NEST) ,
NIST ,
Transparency
On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...more
The Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). FDORA authorizes a variety of new and important amendments to the Food, Drug,...more