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Medical & veterinary products save lives every day. FDA-regulated products such as blood pressure medicine, chemotherapy & MRI machines help people & animals live longer & healthier.

The U.S. Food & Drug Administration regulates human & animal medical products to ensure they are safe & effective. Products undergo different types of testing to determine their safety & effectiveness. These tests may include animal testing, & they almost always include other types of tests.

Here are some facts about animal testing & their alternatives.

Using Scientifically Valid Alternatives to Animal Testing

The FDA encourages & accepts scientifically valid alternatives to animal testing. But validated alternatives to animal testing are not available yet for many medical products.

Product developers must show the FDA that a medical product is reasonably likely to be safe for testing in people. Only scientifically reliable & validated test methods can be used to show product safety before testing in people.

These types of tests are generally referred to as nonclinical tests. There are many types of nonclinical testing. They include:

  • Laboratory tests in a petri dish or test tube, which may include tests with human or animal cells & tissues (in-vitro testing).
  • Computer modeling (in-silico testing).
  • Animal testing (in-vivo testing).

Testing a product with people is called clinical testing, also known as clinical investigation or clinical trials. A product developer collects scientific information from nonclinical testing to show that clinical testing in people is likely to be safe. After the nonclinical testing phase, the FDA may authorize the product developer to conduct clinical testing.

Product developers determine which types of tests they will conduct, in consultation with the FDA, & can use alternative methods to animal testing. They often conduct animal testing at some stage of the product development process because scientifically valid alternatives to animal testing are not available yet.

FDA Supports Developing Alternatives to Animal Testing

The FDA encourages industry efforts to develop & use alternative methods to test the safety of FDA-regulated products. Before researchers use animals for testing, they should consider using scientifically valid alternatives. The FDA has provided guidance to product developers on alternative methods in specific circumstances.

Although a few specific areas have established validated non-animal test methods (for example, skin irritation for dermal products), there are many areas for which alternative testing methods do not exist yet or have not been validated.

Because the body is a highly complex, biological living system that is difficult to replicate in a testing environment, alternative testing methods cannot always predict side effects & safety concerns. Scientists must do more research & validation on alternative testing methods before the procedures can be routinely & more broadly used.

FDA scientists are working together to help in the development of alternatives to animal testing & build confidence in reliability of alternative methods. The FDA is strongly committed to:

  • Reducing the use of animal testing.
  • Replacing animal testing with alternative methods when they are available.
  • Refining animal testing so that the maximum amount of scientific information can be humanely collected with the minimum number of animals.

These priorities – replace, reduce & refine – are known as the “3Rs,” & they guide the FDA in our commitment to alternatives to animal testing.

Scientists at the FDA are working together, & with industry partners, to advance the development & adoption of alternatives to animal testing. For most products under development, there currently aren’t testing methods that can replace animal testing entirely. Researchers & scientists in many areas must do a lot more studies & development to create valid alternative methods.

Federal Laws on the Treatment of Test or Research Animals

Scientists who conduct research with animals must follow the applicable laws, regulations & standards regarding the treatment & care of animals used in research & testing.

These include:

  • The Animal Welfare Act & Animal Welfare Act Regulations from the U.S. Department of Agriculture (USDA).
  • The Public Health Service Policy of Humane Care & Use of Laboratory Animals from the National Institutes of Health Office of Laboratory Animal Welfare (OLAW).
  • The Guide for the Care & Use of Laboratory Animals from the National Research Council.

In all cases where animal studies are used, the FDA advocates that research & testing results in the maximum amount of useful scientific information from the minimum number of animals while using the most humane & scientifically valid methods available.

The FDA supports the transfer, adoption or retirement of research or testing animals, when possible. But the FDA does not own animals used by other organizations, such as product developers & manufacturers, in animal testing & does not control their placement after study.

The FDA shares any concerns about test or research animal welfare with the federal agencies & offices that regulate & enforce standards of animal treatment & care, including the USDA & OLAW.