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Friday, June 23, 2017
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Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA (PRA06)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 3.5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00 LogoTraining Program: Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA
Training Provided By:

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This course discusses FDA expectations of applications for generic product licensing. It provides the background knowledge to effectively assemble, gather, and plan the necessary documentation in order to submit an ANDA (Abbreviated New Drug Application). Timelines are set out and practical advice in the form of a checklist is provided. The Abbreviated New Drug Application process is compared and contrasted with the process that is involved in the NDA.

This course includes sections regarding bioequivalence, the Orange Book, the review and approval processes of ANDA, ANDA submission, patent certification, ANDA and generic drugs, and a regulatory overview.

The entire program must be viewed by students, and a multiple-choice, online final assessments must be completed with a passing grade of 80% or more. Once the program requirements are succeeded, a certificate of completion is immediately achieved. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.

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.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied

The 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):

International Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ … Learn more


Regulatory overview
Module 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.

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.


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