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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

FEBRUARY 2, 2023

The law defines this term to mean “a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug.” Tobolowsky & Charles G. FDORA § 3209(a)(1). FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Is Confirmatory Evidence Having a Moment?

FDA Law Blog

OCTOBER 11, 2022

We use the term “confirmatory evidence” as short-hand for one of the two ways explicitly defined in the Federal Food Drug & Cosmetic Act (“FD&C Act”) for demonstrating substantial evidence of effectiveness. More importantly, replication is but one means to substantiate the results of a clinical investigation or scientific study.

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Bridging Innovation & Patient Care: The Growing Role of AI

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

Is Confirmatory Evidence Having a Moment?

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