E12: GDPR Article 22 and Automated Decision Making
Deloitte: Turnarounds and Democracy Don't Mix
Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence,...more
On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The final guidance reiterates...more
Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more