article thumbnail

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

Agency IQ

European Commission issues EU-wide rules on pesticide ingredients The Commission has issued uniform rules governing data requirements and a work program for safeners and synergists, constituent compounds that, like active substances, must be approved for use in plant protection products in the EU.

article thumbnail

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

Agency IQ

In the post-market space, the group offers guidance on creating a post-market clinical follow-up (PMCF) plan, which confirms product safety and performance and identifies emergent risks ( MDCG 2020-7 ). Some of these are laboratory and animal tests, cadaveric studies and data from similar devices.

Trials 40