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

Agency IQ

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. This also has clear potential to reduce animal testing, another key commitment made by the Commission.

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Analysis Chemical Thank You Explainer: carcinogen classification in the E.U., U.S., and internationally

Agency IQ

This framework is anchored in the Classification, Labeling, and Packaging Regulation (CLP) (1272/2008/EC), the bloc’s definitive legislation on classifying substances and mixtures. This change means that the IARC no longer comments on which substances and activities are not carcinogenic. European Union The E.U.

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

Agency IQ

However, the agency has worked more recently on coating-specific guidance documents for other device types, including a final guidance from October 2019 on intravascular catheter systems with lubricious coatings. Clinical performance testing: Generally, clinical studies are not necessary for metallic and calcium phosphate coated devices.

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Everything Wrong with Mouse Studies (Kinda)

Codon

It did not change at all between the years 1972 and 2019, despite everything I’m about to tell you. Mice raised at five different animal facilities in Europe, under otherwise identical conditions , have “persistent differences in body weight” and behavior. Each animal had a different microbiome.

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Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

BY LAURA DIANGELO, MPH | MAR 6, 2024 5:54 PM CST Fiscal year 2024 appropriations bills On March 3, 2024, House and Senate appropriators released a package of final fiscal year (FY) 2024 appropriations bills. AgencyIQ has the highlights. As POLITICO reported , this generally represents a 5.2% This is already raising some red flags.

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Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

For example, the FDA does not have a proposed rule listed that would change how it regulates animal testing requirements following the passage of the FDA Modernization Act 2.0 It’s also interesting to see what isn’t on this list. provisions of the Food and Drug Omnibus Reform Act (FDORA) in 2022. and the E.C.