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 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 ...

Purchasers of MDR services should be wary of doing so, because with MDR, you truly get what you pay for. By focusing primarily on price and hourly rates, legal teams may fail to protect themselves ...

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 ...

Document review, the most expensive part of the eDiscovery process, often poses a formidable challenge for litigation professionals, especially in large-scale, complex cases. This task is further ...

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 ...