The Center for Law, Health and Society represents the culmination of research, educational and community outreach initiatives developed in the health law field at Georgia State University. For more information about the center, visit clhs.law.gsu.edu.

Prof. Zettler on webinar for National Press Foundation on regulation of bio-tech drugs

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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.

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