Process of 9 Preclinical study clinical trials Learning how a treatment works in test tubes and animals to determine potential safety and effectiveness. Application period Researcher submits an Investigational New Drug (IND) application to the FDA for a proposed clinical trial. Phase I Involves the fewest participants, making sure the therapy is safe, and finding the right dosage. Phase II More participants and researchers look for favorable or useful effects while monitoring safety. Phase III The longest phase, with the most participants, proves the therapy has the desired result while being safe. FDA final approval Biologics License Application (BLA) is submitted to the FDA and is thoroughly reviewed to determine approval. 2023 Benefits Trends: The evolving workplace 66