How Do Clinical Trials Fit into the Regulatory Process?
Clinical trials are a critical component of the regulatory process. They are typically conducted in three phases:
Phase I: Assesses safety and dosage in a small group of participants. Phase II: Evaluates efficacy and side effects in a larger group. Phase III: Confirms efficacy and monitors adverse reactions in a large population.
Upon successful completion of these phases, a New Drug Application (NDA) or Biologics License Application (BLA) is submitted to the regulatory agency for review.
