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

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Program/Course ID: PRA006 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Saturday, May 16, 2026 UPDATE:
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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Outline: 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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Comments: For quotes or invoices please provide the titles of the course(s) and number of students.	Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA