If a country is not listed in the high-risk category or the low-risk category, the EC has assigned it a standard level of ...

In a surprise post this afternoon, new FDA Commissioner Dr Martin Makary announced a completed pilot at the FDA of a generative AI-based system for speeding up drug review - and plans to roll out ...

The FDA has said it will expand unannounced inspections of overseas manufacturing facilities supplying medicine and other medical products to the US. The aim is to make sure that foreign companies ...