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

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biobide

AUGUST 18, 2023

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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Agency IQ

JULY 22, 2024

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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Drug Target Review

SEPTEMBER 26, 2023

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.

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Agency IQ

JUNE 7, 2024

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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Agency IQ

OCTOBER 12, 2023

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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Agency IQ

JANUARY 19, 2024

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.

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