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

Agency IQ

New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. Does this guidance offer the formal definition of “orphan device” we’ve been waiting for?

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

Agency IQ

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.

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Ceracare

The Pharma Data

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Definitely not! of our 3 or 6 bottle discount package. . Ceracare is a natural supplement containing powerful antioxidants that help support detoxify your body and support blood sugar.

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Unity

The Pharma Data

Antibiotic Free, Gluten Free, NON-GMO, Manufactured in an FDA Registered Facility & No animal testing! Definitely not! Therefore, we strongly recommend you take advantage of our 3 or 6 bottle discount package. . Unity gathers the freshest and highest quality natural ingredients available.

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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. European Union The E.U. Currently, the CLP is aligned with parts from the sixth and seventh revised editions of the GHS.

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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 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. billion in “definite user fees.” AgencyIQ has the highlights. The total budget of ~$6.7 billion includes ~$3.5

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