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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

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. adequate to justify the proposed clinical testing.” 21 U.S.C. §

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The 3Rs Principles in Cosmetic and Self-care Industry: the Regulation that Prioritises Animal Welfare

biobide

With an increased focus on animal welfare , the beauty industry has undergone a shift towards the 3Rs Principle application and all surrounding regulations. In 2004 the European Union (EU) introduced a ban on animal testing on finished products.

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Article Periodic Thank You Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

Commission unveils details on plan for phasing out animal testing for chemicals safety At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment.

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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

Our approach to seizure liability screening is especially pertinent in the context of the recent FDA modernization act which allows applicants to use methods other than animal testing to establish drug safety and effectiveness. 2009 Sep;14(17–18):876–84. Neurotoxicology. 2010 Aug;31(4):331–50. Drug Discov Today.

Drugs 111
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Article Periodic Thank You European Commission issues EU-wide rules on pesticide ingredients

Agency IQ

Like the registration requirement under REACH, this provision has been added to support data sharing for the same substances, to help limit potential data gaps among individual companies and, in turn, decrease the need for resorting to animal testing.

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Analysis Chemical Thank You EU court upholds ban on chlorpyrifos-methyl, setting regulatory precedent in the process

Agency IQ

The governing framework regulations here are firstly the Plant Protection Products Regulation (PPPR) (1107/2009/EC) and secondly Implementing Regulation (EU) No 844/2012. It also found this approach beneficial because it reduces the need for animal testing.

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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

This also has clear potential to reduce animal testing, another key commitment made by the Commission. However, the newly proposed Regulation aimed at reattributing tasks, commonly called the Omnibus Regulation, seeks to accomplish this task with respect to four existing chemical regulations.