medicines-medical devices-regulatory affairs
This guidance has been updated to include sections on the following: Lifecycle management MAHs are reminded of their responsibilities to ensure the quality, safety and efficacy of their medicines and are expected to continue to review and re-visit the outcome…
Swissmedic enshrines the requirement to submit risk assessments regarding nitrosamines in active substances and/or finished medicinal products in the relevant specification documents. Update 18 June 2025 Source: Swissmedic
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…