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Article EMA Thank You With all nitrosamines deadlines passed, EMA updates its guidelines

Agency IQ

NOVEMBER 27, 2023

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%

Regulations

Regulations Production FDA Packaging

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

Agency IQ

AUGUST 11, 2023

FDA

FDA Science Production Regulations

Drug Discovery Digest

Article EMA Thank You With all nitrosamines deadlines passed, EMA updates its guidelines

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

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