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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed. All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity.

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Analysis Life Sciences Thank You FDA lays out new assessment framework for certain nitrosamines

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EMA’s investigation ended up revealing even more causes of nitrosamine impurities in drugs, discovering, for example , that formation happened during the heat-sealing process of in certain products using blister-packaging. In a study of more than 12,000 small molecule drugs , researchers found 40.4%

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