In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions In addition, with the passage of GUFDA II which significantly changes the fee structure, it is also crucial to understand the major changes to the program, and the effects of those changes on the generics industry. This webinar explains the submittal process of drugs and medicinal products and also explores the GUFDA II Guidance.