ANDA: How to Gain Approval to Market a Generic Drug in the USA

Need details on how to get a generic drug approved to market in the US? A sponsor of a generic drug must submit an Abbreviated New Drug Application (ANDA) to request and receive approval from the Food and Drug Administration (FDA) to market the drug in the US. Take a deep dive into this module to learn the regulatory requirements for submitting an ANDA to the FDA. In addition, this module covers the FDA’s review and approval process.

Familiarize yourself with the different criteria for the different types of patent classification and formatting requirements. Additionally, learn about criteria for the therapeutic equivalence and bioequivalence of drug products.

This course will benefit staff working in regulatory affairs, medical affairs, clinical development, quality/CMC, analytical methods, and quality assurance departments, and other personnel who contribute to the development and registration of generic drugs.

The course is up to date with the many final and draft publications, recently released by the FDA, that provide guidance for industry on applications for approval of generic drugs. It is also up to date with the provisions of the third authorization of GDUFA, applicable in US fiscal years 2023 to 2027.

The course covers:

• 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; a summary of the criteria for therapeutic equivalence of drugs; obtaining guidance from the FDA; controlled correspondence.
• 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; submitting an ANDA to the FDA’s Office of Generic Drugs.
• ANDA review and approval – The process of review by the FDA; review duration and success rate; communication between applicant and FDA; expedited review; petitions; amendments and easily correctable deficiencies; 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; changes brought about by GDUFA II.