Animal Medicine

Animal Health Products and Veterinary Market (Developing Veterinary Drugs and Biologics)

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The Food and Drug Administration (FDA) regulates all animal products: The FDA-Center for Veterinary Medicine regulates drugs. The United States Department of Agriculture (USDA) – Center for Veterinary Biologics regulates diagnostics, vaccines, immune based products (immune modulators and immune stimulants), and immunoglobulin products.

The Food and Drug Administration (FDA) regulates all animal products: The FDA-Center for Veterinary Medicine regulates drugs. The United States Department of Agriculture (USDA) – Center for Veterinary Biologics regulates diagnostics, vaccines, immune based products (immune modulators and immune stimulants), and immunoglobulin products.

How to Develop and Animal Health Product

Define the regulatory path: The first step is to understand which regulatory agency will oversee the development of the technology or service. Once this is defined, it will set the foundation for the necessary clinical trials, manufacturing, labeling, promotional materials, and other aspects that will define the product or service.

Veterinary medicine is a multi-billion dollar market. In recent years, an increasing number of biomedical companies (biotech, pharmaceutical, biopharmaceutical, medical device, and diagnostic) have initiated efforts to advance their technologies and/or services into the animal health market.

Misconceptions

The process is simple. The process to get a veterinary product approved is not simple, and often requires years of work to obtain the necessary data to obtain an approval and support the product in the market.

Far too often, someone tries to develop a product for veterinary medicine only to find out they did not have the expertise or understanding (regulatory, market, etc.) to effectively develop the product. There are several consulting groups that can advise on how to develop veterinary products or those for the pet market.

What are the Biggest Markets

How to get Started

Companion animals (dogs, cats, horses) often represent the largest spending per species per visit. Minor species (ferrets, rabbits, etc) is a growing market, and the FDA has recently enacted the Minor Use Minor Species Act (MUMS Act) to facilitate the develop of drugs for these species.

Define the clinical path: Next, determining which trials (GLP, GCP) in target species will be required to support label claims and the approval. Don’t assume that previous lab animal work or unapproved studies will support your approval process.

Define the market strategy and economics: After the regulatory path, clinical path, and timeline are estimated, it is very important to understand the economics of the market you are proposing to go into. There is a limit, as with any market, on the cost of treatment.

To Develop and Animal Health Product

Define the regulatory path: The first step is to understand which regulatory agency will oversee the development of the technology or service. Once this is defined, it will set the foundation for the necessary clinical trials, manufacturing, labeling, promotional materials, and other aspects that will define the product or service.

Veterinary medicine is a multi-billion dollar market. In recent years, an increasing number of biomedical companies (biotech, pharmaceutical, biopharmaceutical, medical device, and diagnostic) have initiated efforts to advance their technologies and/or services into the animal health market.

Misconceptions

The process is simple. The process to get a veterinary product approved is not simple, and often requires years of work to obtain the necessary data to obtain an approval and support the product in the market.

Far too often, someone tries to develop a product for veterinary medicine only to find out they did not have the expertise or understanding (regulatory, market, etc.) to effectively develop the product. There are several consulting groups that can advise on how to develop veterinary products or those for the pet market.

What are the Biggest Markets

How to get Started

Animal Health Products and Veterinary Market (Developing Veterinary Drugs and Biologics).

Companion animals (dogs, cats, horses) often represent the largest spending per species per visit. Minor species (ferrets, rabbits, etc) is a growing market, and the FDA has recently enacted the Minor Use Minor Species Act (MUMS Act) to facilitate the develop of drugs for these species.

Define the clinical path: Next, determining which trials (GLP, GCP) in target species will be required to support label claims and the approval. Don’t assume that previous lab animal work or unapproved studies will support your approval process.

Define the market strategy and economics: After the regulatory path, clinical path, and timeline are estimated, it is very important to understand the economics of the market you are proposing to go into. There is a limit, as with any market, on the cost of treatment.

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