A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

For multi-year projects reviewed by the convened IRB, continuing IRB review and approval is required. Additionally, the IRB may require continuing review when other regulations apply (e.g. FDA, ...

Document intelligence startup Klarity Intelligence Inc. said today it has raised $70 million in new round of funding led by Nat Friedman and Daniel Gross. Scale Venture Partners, Tola Capital, Picus ...

Document Crunch's artificial intelligence-enabled agents can highlight problematic language in contracts, change orders or any construction documents at any stage of a project. Appleton, Wis.-based ...

A new contender has entered the scene: generative AI (GenAI). This groundbreaking technology is poised to redefine document review, addressing the gaps TAR struggles to fill. The legal world has long ...

The evidence supporting GenAI is compelling, and it's time to explore what this technology can offer. Those who hesitate risk falling behind in a rapidly evolving industry. Recently, I was asked why ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

An 18-month-long investigation conducted by the House Committees on Oversight and Reform and Energy and Commerce found that the Food and Drug Administration’s controversial approval of the Alzheimer’s ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...