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This course, a LeoPink Limited eLearning module, outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of an Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drugs User Fee Amendments of 2012 and the law’s effects on generics sponsors. Finally, the different regulatory pathway that applies to the licensure of copies of biological products is described, including the requirements of the Biosimilar User Fee Act of 2012.

The module takes an average of 3.5 hours to complete. (Note that this is an average time. People learn at different rates, and they explore resources and examples at different paces.)

Featured topics

  • Generic drugs and the ANDA
  • Patent certification
  • The Orange Book
  • Bioequivalence
  • The ANDA submission
  • The ANDA review and approval
  • The Generic Drugs User Fee Amendments
  • Biological products

Who should attend?

This module is intended primarily for:

  • Regulatory affairs professionals dealing with ANDAs or 351(k) applications
  • All those involved in the development and registration of generic drugs or follow-on biologics

Learning objectives

Participants who complete this course should be able to:

  • List the criteria for therapeutic equivalence of drugs
  • Outline the types of patent classification for an ANDA submission
  • Explain how to use the Orange Book in the development of a generic drug
  • Describe methods for determining bioequivalence of drug products
  • Outline the content and format requirements for an ANDA submission
  • Describe the ANDA review and approval process
  • Outline the provisions of the Generic Drugs User Fee Amendments and summarise their effects on generics sponsors
  • Identify the main regulatory provisions that apply to the licensure of follow-on biological products

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