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

Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA (PRA006)

Certification Training
Duration: 2 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
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Certificate: View sample certificate.

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BioPharma Institute LogoTraining Program: Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute ReviewsThis course describes FDA expectations of applications for the licensing of generic products. It provides the background knowledge to effectively plan, gather and assemble the necessary documentation for the submission of an Abbreviated New Drug Application (ANDA). Practical advice in the form of checklists is provided, and timelines are set out. The ANDA process is compared and contrasted with that for the NDA.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA course is found in the following professional certification program(s):

Professional Designation in US Pharmaceutical Regulatory Affairs: ... Learn more


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.


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.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
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  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
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