Pharmaceutical Regulatory Affairs: How to Gain Approval to Market a Generic Medicinal Product in the USA

  • ID: 2863530
  • Training
  • Region: United States
  • Leopink
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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.

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
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Module overview
An outline of the module’s scope and objectives, and notes on terminology.

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.

Assessment
Multiple-choice mastery assessment.
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