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

Agency IQ

JUNE 7, 2024

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

Agency IQ

JUNE 28, 2024

Other work packages for the ODTF include information about clinical evidence for this device type, conditional certification, and the use of registries to support conformity assessment. Some of these are laboratory and animal tests, cadaveric studies and data from similar devices.

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Trials Marketing Clinical Trials Regulations 40
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