Biosimilars, Cell Based Assays and Drug Development

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Drug Development

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

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. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. § 42 U.S.C. §

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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