US FDA consults on applying ICH stability testing guides for new drugs to generics
This article was originally published in SRA
To standardise its stability testing policies for medicines, the US Food and Drug Administration has proposed applying to generic drugs stability testing guidelines developed by the International Conference on Harmonisation for new drug products1,2.
You may also be interested in...
The EU network of health technology assessment bodies says it is seeing the benefit of systematically involving patients when companies approach it for early scientific advice on evidence generation.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-eight guidance documents have been posted on the tracker since its last update.