February 1, 2023

FOOD AND DRUG ADMINISTRATION no longer needs to require animal tests before human medication trials

Legislation allows FDA to promote a drug or biologic—a larger molecule such as an antibody—to human trials after either animal or nonanimal medical tests

New medications need not be tested in animals to receive U. Ersus. Food and Drug Administration (FDA) approval, according to legislation authorized by President Joe Biden in late December 2022.

The change— long sought simply by animal welfare organizations— can signal a major shift far from animal use after greater than 80 years of drug
safety regulation.

“ This is huge, ” says Tamara Drake, movie director of research and regulatory policy at the Center to get a Humane Economy, a nonprofit animal welfare organization plus key driver of the laws. “ It’s a win meant for industry. It’s a win with regard to patients in need of cures. ”

In place of the 1938 stipulation that possible drugs be tested intended for safety and efficacy in animals,   the law   allows FOOD AND DRUG ADMINISTRATION to promote a drug or biologic— a larger molecule for example an antibody— to individual trials after either animal or nonanimal tests. Drake’s group and the nonprofit Pet Wellness Action,   among others   that will pushed for changes, believe in clearing drugs with regard to human trials the agency should rely more seriously on computer modeling, “ organ chips, ” and other nonanimal methods that have been developed over the past 10 to 15 years.

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