FDA Office of Generic Drugs and Advancing Generic Drug Development
A convoluted network of diverse worldwide regulatory demands can hinder patients from obtaining generic medications. During this presentation, we will present global initiatives and participation in different regulatory domains, such as ICH, IPRP, GBHI, among others. The FDA OGD global affairs program will share the latest information regarding the Generic Drug Cluster and parallel Scientific Advice (PSA). We will discuss the benefits of a global harmonization that may enable quicker access to high quality, safe and effective generic drugs for patients.
- Mathew Cherian PhD, VP of Operations & Development ReVive Biotechnolohy, United States
- Nikolina Biskic, Regulatory Affairs Manager Bayer, Switzerland
- Sarah Ibrahim PhD, Associate Director, Office of Generic Drugs Food and Drug Administration (FDA), United States