How to Gain Approval to Market a Generic Medicinal Product in the USA - E-Learning Module

  • ID: 3699400
  • Training
  • Region: Global, United States
  • 210 Minutes
  • Zenosis Limited
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This 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.

Who will benefit from this module?

This module is intended primarily for regulatory affairs professionals dealing with ANDAs or 351(k) applications. However, it will be of value to all those involved in the development and registration of generic drugs or follow-on biologics.

Learning objectives:

- 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

CPD Points: 3.5

Assessment: Multiple-choice mastery assessment.
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Generic Drugs and the ANDA - An overview of the legislative and regulatory context for the development and approval of generic drugs, particularly the Hatch-Waxman Act, and a summary of the criteria for therapeutic equivalence of drugs.

Patent certification - The role of patent certification in an ANDA submission, the different types of certification, what happens when a patent is challenged, and the circumstances under which marketing exclusivity may be afforded to a generics sponsor.

The Orange Book - The use of the Orange Book in generic drug development, the format and content of the Book’s listings, and how to extract information for an ANDA.

Bioequivalence - The crucial importance of establishing bioequivalence with a reference listed drug; tests of bioavailability and bioequivalence; the statistical criteria for bioequivalence; waivers of in-vivo studies.

ANDA compilation and submission - Planning and managing an ANDA project; regulatory requirements on content and format; quality (CMC), labeling, and bioequivalence information; guidance regarding question-based review of quality information; submitting an ANDA to the FDA.

ANDA review and approval - The process of review by the Office of Generic Drugs (OGD); review duration and success rate; communication between applicant and OGD; outcomes of review, and the applicant’s options in response to those outcomes.

The Generic Drugs User Fee Amendments - The types of fees that the generics industry must now pay to the FDA; requirements for self-identification of generics industry players; the FDA’s performance goals for review and inspection.

Biological products - Regulatory requirements for the development and licensure of follow-on biologics; 351(k) applications; criteria for biosimilarity and interchangeability; market exclusivity; patent infringement issues; requirements of the Biosimilar User Fee Act.
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