24 November 2021 - Pharmavibes

Public consultation, TGA (Australia)

TGA consults on remaking of legislative instruments for human cell and tissue (HCT) products

Last updated on: 24 November 2021. See update at the end of the post. TGA, Australia is consulting on the remaking of some TGOs and other legislative instruments for human cell and tissue (HCT) products. What are Therapeutic Good Orders…

24 November 2021

nitrosamines, US FDA

FDA updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products

The FDA has recently updated its information on possible mitigation strategies to reduce the risk of nitrosamine drug-substance related impurities in drug products (NDSRIs). Guidance for industry on nitrosamine was published in September 2020 and updated in February 2021. A…

24 November 2021