FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

In effect, the revisions to the FD&C Act and the PHS Act are designed to encourage the use of alternatives to animal testing not eliminate animal testing in drug development. adequate to justify the proposed clinical testing.” The pre-existing statutory language did not require animal testing.

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays Clinical Trials 64

Agency IQ

OCTOBER 12, 2023

The Court maintained that, to annul this non-renewal on the basis of a lack of transparency, the firms would have to identify “an express provision conferring on [them] a procedural right” within the relevant governing framework legislation to be informed of these developments.

Regulations 40

Regulations Animal Testing Government Production 40

Agency IQ

JUNE 7, 2024

European Commission issues EU-wide rules on pesticide ingredients The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU.

Regulations 40

Regulations Animal Testing Production Marketing 40

Agency IQ

MARCH 7, 2024

At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition Last week, EU chemicals regulator ECHA brought together experts from industry, government, civil society, research, and academia to discuss the future of EU chemicals regulation.

Regulations 40

Regulations International Government Compliance 40

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. million scientific procedures involving live animals were carried out in 2020. million scientific procedures involving live animals were carried out in 2020. In Britain, 2.88 In Britain, 2.88

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Animal Testing Drugs Clinical Trials Clinical Research 105

Agency IQ

AUGUST 18, 2023

varies based on government agency. E Evidence of Non-carcinogenicity for Humans Agents that show no evidence for carcinogenicity in at least two adequate animal tests in different species or in both adequate epidemiologic and animal studies.

International 40

International Regulations Packaging Animal Testing 40

Codon

JULY 21, 2024

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

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Research Engineering Disease Science 122