Cell Based Assays and Licensing - Drug Discovery Digest

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Cell Based Assays

Licensing

Exploring alternatives to animal testing in drug discovery

Drug Target Review

JULY 6, 2023

allowing researchers to use “certain alternatives to animal testing, including cell-based assays and computer models, to obtain an exemption from the FDA to investigate the safety and effectiveness of a drug.”

Animal Testing

Animal Testing Drugs Clinical Trials Clinical Research

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

The definition goes on to list potential options for such tests: cell-based assays, organ chips and microphysiological systems, computer modeling, other nonhuman or human biology-based test methods such as bioprinting, as well as animal tests. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

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Bridging Innovation & Patient Care: The Growing Role of AI

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Exploring alternatives to animal testing in drug discovery

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

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