Regulation and Prevalence of Bio-Tech Drugs: How Regulation of Biologics Differs from Traditional Prescription Drugs” posted on Sept. 24. The process of developing a new drug and getting it approved by the FDA takes approximately 10 years, requiring animal testing,3 phases of clinical trials in humans, and a New Drug Application or Biologic License Application. Biosimilars, which are “similar” to the new bio-tech drugs but not identical, are raising new questions about the approval process.
Patricia J. Zettler is an associate professor at Georgia State University College of Law and was a former attorney with the Food and Drug Administration. Zettler’s research focuses on the regulation of medicine, biotechnology, and biomedical research, as well as food and drug policy.