Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA
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2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:Regulatory overview: course scope and objectives, areas not covered, and the US legislative framework. Generic drugs and the ANDA: In this session a high level overview of the requirements and processes necessary to gain successful FDA approval are provided. Patent certification: This session distinguishes the different types of patent classification that can be submitted as part of an ANDA, what happens when a generic patent is challenged, and the exclusivity open to a generic company. The ANDA submission: The format and content of the ANDA (traditional, CTD, and eCTD) with reference to 21 CFR are presented in this session. The ANDA review and approval process: This session delves deep into the FDA review and approval process and covers the common issues, requirements and guidance for a successful initial submission. The Orange Book: How to query the electronic Orange Book, and the searches necessary to extract the relevant information to assist in an application are covered in this session. Bioequivalence: This session explores the purpose of bioequivalence and its importance for approving an ANDA. It covers the terminologies of therapeutic equivalents, pharmaceutical equivalents and pharmaceutical alternatives, and defines what a bioequivalent drug product is. | Objectives:Students completing 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. | |
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