Drug Discovery World

AUGUST 13, 2024

Professor Andy Whiting , CEO of Nevrargenics, asks whether animal models should be used as the default regulatory requirement and explores the times to use them. Animal models (AMs) have generally been seen as useful for drug development and biomedical research for many years. Are AMs always necessary and unavoidable?

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Drug Development Animal Testing Regulations Drugs 163

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I). 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Animal Testing Biosimilars Cell Based Assays FDA 64

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out. The US FDA Modernisation Act 2.0.,

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. Nonclinical studies encompass much more than just animal studies.

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FDA Science Small Molecule Immune Response 40

The Premier Consulting Blog

APRIL 25, 2023

As a result, the FDA is now required to consider alternatives to animal testing, such as in vitro , in silico , and in chemico tests and models. In this blog post, we examine several alternative approaches to animal testing and how the FDA handles the application of these methods in specific scenarios.

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FDA Animal Testing Pharmacokinetics Small Molecule 52