Health Canada Makes Clinical Information on Medical Devices Publicly Accessible

Health Canada Makes Clinical Information on Medical Devices Publicly Accessible

Health Canada Makes Clinical Information on Medical Devices Publicly in a significant move toward greater transparency in healthcare, Health Canada (HC), the country’s medical device regulator, has announced that clinical information submitted in support of medical device applications is now publicly available. This development marks a crucial step in empowering healthcare professionals, researchers, and the general public with access to critical data.

FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development

FDA Proposes Framework to Bolster Credibility of AI Models in Drug Development

The U.S. Food and Drug Administration (FDA) has unveiled a groundbreaking draft guidance aimed at advancing the credibility of artificial intelligence (AI) models in drug and biological product development. This marks a significant milestone as it is the agency’s first formal guidance on AI in this domain, underscoring its commitment to innovation while maintaining rigorous regulatory standards.