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

Agency IQ

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

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The essential role of recombinant phage display antibody libraries

Drug Target Review

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Recently, the FDA announced that new medicines need not be tested in animals to receive regulatory approval. Antibodies to watch in 2024. 2024 Jan 5;16(1). 1975 Aug;256(5517):495–7.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

between 2024 and 2030. One of the key challenges that accompanies this early phase of drug development is ensuring the preclinical CRO’s team of scientists select effective tests to accurately evaluate a new drug candidate. billion in 2023 and is expected to grow at a CAGR of 7.0%

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Article FDA Thank You FDA proposes first update to orthopedic device coating guidance since 1990s

Agency IQ

BY LAURA DIANGELO, MPH | JAN 23, 2024 12:15 AM CST Orthopedic, implanted medical devices and coatings: Regulatory recap Medical device materials, and coating: In general, the types of materials and components of which medical devices are constructed need to be evaluated for their impact on a device’s performance and safety. What’s next?

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Article Periodic Thank You EPA issues new chemicals decision framework to assess eye irritation and corrosion

Agency IQ

The framework supports EPA’s mandate to develop and implement alternative test methods and strategies, or new approach methodologies (NAMs), that do not require vertebrate animal testing for assessing risk of injury to health or the environment. EPA proposed updates to New Chemicals Regulations under TSCA in May 2023.

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Raising Welfare for Lab Rodents

Codon

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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How Lume Whole Body Deodorant Was Inspired by a Genetic Disease

PLOS: DNA Science

Fishy Regulations Lume falls under the cosmetic category at FDA and so needn’t have undergone clinical trials, because it doesn’t treat an illness or condition. If each ingredient is recognized as safe, then manufacturing complies with FDA regulations. It debuted in January 2024 , but the company has been around since 2015.

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