The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA

This course, a Zenosis® eLearning module, describes the US Food and Drug Administration’s (FDA) expectations when reviewing applications for the licensing of generic pharmaceuticals and medical products. Learners will receive the background knowledge necessary to draft an effective submission for an abbreviated new drug application (ANDA). The course reviews the Hatch–Waxman Act, the law that promotes generic drug development. The ANDA process is also compared and contrasted with the new drug application (NDA) process. The module describes the regulatory role of the FDA in the generic drug approval process so that learners fully understand how to develop and submit a successful ANDA. Practical advice, checklists, and timelines are provided.

• Generic drug approval criteria
• Overview of ANDA process
• Overview of Hatch–Waxman Act

• Regulatory affairs and compliance staff
• Personnel who contribute to regulatory submissions

Participants who complete this course should be able to:

• Outline the FDA generic drug approval system
• Describe the differences between the generic drug approval process and the new drug approval process
• Identify information contained in the “Orange Book”
• Describe the methodology for determining bioequivalence of drug products
• Explain how to develop and submit a successful ANDA