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

Agency IQ

By July 19, 2024, the Commission will publish a list of the safeners and synergists already on the EU market as of June 19, 2024. Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances.

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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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Article Periodic Thank You At conference, ECHA calls for regulatory coherence, collaboration to achieve green and digital transition

Agency IQ

BY SCOTT STEPHENS, MPA | MAR 7, 2024 8:21 AM CST The format: an emphasis on conversations ECHA’s one-day event , titled “Shaping Tomorrow,” was held at the agency’s headquarters in Helsinki, Finland and live-streamed on ECHA’s website. Among the topics: stakeholder cooperation in the context of the green and digital transition.

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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. Finally, MDCG 2024-3 outlines the expected content for a clinical investigation plan and MDCG 2024-5 describes the content of the investigator’s brochure.

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A therapy candidate for fatal prion diseases turns off disease-causing gene

Broad Institute

By Greta Friar, Whitehead Institute June 27, 2024 Images of a mouse brain show the effect of a technology called CHARM in turning off the expression of a gene in the brain. The first problem they had to tackle was the editor’s size, because the editor needs to be small enough to be packaged and delivered to specific cells in the body.

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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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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. increase in base salaries for federal workers in 2024, which started in January.

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