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

Agency IQ

The PPPR framework governs the authorization, sale, and use of PPPs, establishing a pre-market approval process for active substances – the pesticide components which control pests, weeds, and plant diseases – and for synergists and safeners before they can be allowed for use in PPPs.

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

Agency IQ

The working definition offered at that meeting focused on devices intended to treat or diagnose patients for diseases or conditions affecting no more than 1 in 37,000 Europeans per year. Those criteria are that the device is intended to benefit patients with a disease or condition present in 12,000 or fewer people in the E.U.

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