**Last week US FDA has released Generic Drugs- Science & Research Priorities for year 2024. It has identified 8 priorities for this year.
Nitrosamines was mentioned as first in the list-
- Nitrosamines (The formulation and manufacturing mitigation strategies and their effects on absorption and/or bioavailability of APIs, Utilizations of simulation and modelling to assess the performance of generic product in the event of re-formulation, Developing analytical methods, and approaches using orthogonal methods, Consideration of tertiary amines beyond secondary amines or other factors that may improve the ability to predict formation of NDSRIs or small molecule nitrosamines, Estimating AI using toxicology studies and QSAR).
We may see more developments, guidance and dialogues with US FDA on these!
FY 2024- US FDA Generic Drugs Research Priorities.pdf (126.4 KB)