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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.

Regulations 40
Regulations Animal Testing Production Marketing 40
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Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs

Agency IQ

JUNE 28, 2024

Some of these are laboratory and animal tests, cadaveric studies and data from similar devices. Manufacturers’ direct consultation of the expert panel is an extraordinary measure allowed only during the MDR transition period, ending in December 2028 at the latest. This would entail review of the CER and orphan device status.

Trials 40
Trials Marketing Clinical Trials Regulations 40
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