Resources
Feasibility: Help or Hinderance in Clinical Trial Start-up?
The site feasibility process has been a source of angst among Sponsors/CROs and sites for years. The process is clunky, repetitive and very time consuming for all involved. In 2021, the American Society of Clinical Oncology (ASCO) Task Force assessed the issue and...
Proposed Legislation Aims to Expand FDA’s DTC Toolkit
Last February, Senate leaders addressed FDA Commissioner Robert Califf, M.D. asking the Agency to close “gaping holes” in the current regulations with regard to Direct-to-Consumer (DTC) prescription drug promotion on social media, pointing out that the last time the...
Implications of FDA’s New Rule on Laboratory-Developed Tests (LDTs) for Clinical Laboratories
On April 29, 2024, FDA introduced a significant regulatory shift affecting the landscape of diagnostic testing: the new rule governing Laboratory-Developed Tests (LDTs). Unlike commercially available tests that are subject to premarket approval by the FDA, LDTs were...