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Perspective

Overview of the Animal Health Drug Development and Registration Process: An Industry Perspective

, , , &
Pages 881-886 | Published online: 06 Jun 2011
 

Abstract

Products for animal health commercialization follow a structured progression from initial concept through to regulatory approval. Typically, products are developed for use in either food animals or companion animals. These can be for the intention of disease intervention, productivity enhancement or improvement in a quality of life capacity. The animal health industry is a regulated industry, meaning that a government agency is responsible for oversight of products, both pre- and post-approval. There are three primary US government agencies that ensure quality, safety and effectiveness for the approval of new products and post-marketing compliance.

Financial & competing interests disclosure

All authors are employees of Elanco Animal Health, a division of Eli Lilly & Company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Notes

Data from Citation[110,111].

Additional information

Funding

All authors are employees of Elanco Animal Health, a division of Eli Lilly & Company. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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