FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.”

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Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Discovery World

MAY 9, 2023

The recent passage of the FDA Modernization Act, which removed the requirement for animal testing when suitable alternatives are available, has highlighted the inadequacy of animal models most often used for in vivo research. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

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Drug Development Clinical Trials Animal Testing Cell Based Assays 130

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

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Animal Testing Drugs Clinical Trials Clinical Research 105

Drug Discovery World

FEBRUARY 2, 2023

To assess whether or not the industry currently has what it needs to move into an era of animal-free drug testing, it is important to look at what the FDA Modernization Act 2.0 ends a federal mandate that experimental drugs need to be tested on animals before they can be used in human clinical trials 2.

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Animal Testing FDA Clinical Trials Drugs 130

Drug Discovery World

APRIL 12, 2023

Products and technologies such as cell-based assays, microphysiological systems and computer modelling will now all be regarded as suitable alternatives to animal testing in the early phases of drug development. The limitations of animal studies are widely documented. Reference Mak IW, Evaniew N, Ghert M.

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FDA Animal Testing Cell Based Assays Clinical Trials 130