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The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. [1]
The law allows drug companies to find alternative methods of assessing their products, without testing them on animals or human beings. The bill was sponsored by Sens. Rand Paul (R–Ky.) and Cory ...
Animal testing regulations are guidelines that permit and control the use of non-human animals for scientific experimentation.They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
Animal testing, also known as animal experimentation, animal research, and in vivo testing, is the use of non-human animals, such as model organisms, in experiments that seek to control the variables that affect the behavior or biological system under study. This approach can be contrasted with field studies in which animals are observed in ...
The FDA has its own requirements for animal research, known as Good Laboratory Practice, to demonstrate that any scientific data being collected in the development of a drug or medical device is ...
In 1954, the Universities Federation for Animal Welfare (UFAW) decided to sponsor systematic research on the progress of humane techniques in the laboratory. [2] In October of that year, William Russell, described as a brilliant young zoologist who happened to be also a psychologist and a classical scholar, and Rex Burch, a microbiologist, were appointed to inaugurate a systematic study of ...
the guidelines, titled "Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry," it added, is the latest move to support its Closer to Zero ...
Minor animal species include animals other than cattle, swine, chickens, turkeys, horses, dogs, and cats. CVM monitors the safety of animal foods and medications. Much of the center's work focuses on animal medications used in food animals to ensure that significant drug residues are not present in the meat or other products from these animals.