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Cell Based Assays

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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

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. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

Animal Testing

Animal Testing Biosimilars Cell Based Assays Clinical Trials

Exploring alternatives to animal testing in drug discovery

Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 3 The first act was approved in 1938 in response to a drug — elixir sulphanilamide — that caused 105 deaths after researchers failed to test the antibiotic before release.

Animal Testing

Animal Testing Drugs Clinical Trials Clinical Research

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Drug Discovery Digest

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

Exploring alternatives to animal testing in drug discovery

Webinars

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