An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.
Why Should You Attend:
Anyone participating with the submittal process must understand how the process is structured and operated in order to bring generic pharmaceuticals and therapeutic products to market properly, successfully, and expeditiously. Furthermore, with the passing of GUFDA II, which drastically alters the fee structure, it is critical to comprehend the program's fundamental changes as well as their implications for the generics market.
Areas Covered in the Webinar:
Who Will Benefit:
The audience for this webinar would consist of anyone in the generic pharma business in the following functions:
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