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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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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Animal Testing Biosimilars Cell Based Assays FDA 64

Agency IQ

AUGUST 4, 2023

Commission redoubles commitment to reduce animal testing in response to Citizens’ Initiative The European Commission provided its mandatory response to a citizens’ petition this week urging faster action to reduce and ultimately eliminate animal testing within the cosmetics and chemical sectors.

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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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Regulations Animal Testing Production Treatment 92

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.

Regulations 40

Regulations Animal Testing Production Marketing 40

Drug Discovery World

JULY 20, 2023

Giannuzzi gave several examples of drugs successfully repurposed for paediatric use: Sildenafil, which was approved in 1998 and then in 2009 for children; Propranolol, which was first approved in 1967 and finally licensed in children in 2014; and Thalidomide, which was approved in 1998 for use in children.

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Clinical Pharmacology Clinical Trials Drugs Trials 100

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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Regulations Animal Testing Government Production 40