Day: May 2, 2024

A new guidance document released this week encourages sponsors of Phase 3 and post-market clinical trials to consider selective safety data collection (SSDC) whereby safety data is limited to major adverse events. The guidance will be hard to follow by the sponsors who are used to collecting detailed safety data in all trials, but does … Read more

As promised last year, this Monday FDA released the final rule formally eliminating the 30-year-old “enforcement discretion” for Lab Developed Tests (LDTs) by requiring all such tests to be formally regulated. The final rule contains critical timelines and clarifications and is accompanied by two new guidance documents. New LDTs will cease to exist immediately and … Read more