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The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats.
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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.
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Hojsik, a member of EP’s Renew Europe group, highlighted the revision of the regulation on the classification, labeling and packaging of chemicals (CLP) and its inclusion of new hazard classes as an important achievement over the past five years.
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 animaltests, cadaveric studies and data from similar devices.
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Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.
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Though my focus in this essay is narrow — I don’t discuss bottlenecks in clinical trials, human disease, or animaltesting — I hope others will take on these challenges in similar essays. This essay focuses on how we might do both, specifically for the cell. Subscribe to Asimov Press.
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