Will the US FDA accept foreign clinical trials?

Will the US FDA accept foreign clinical trials?

In the past, the FDA only accepted clinical studies that were conducted in the United States. However, in recent years, the FDA has begun to accept clinical studies that were conducted in other countries. This is because the FDA recognizes that high-quality clinical...
FDA approval pathways: the 505b2

FDA approval pathways: the 505b2

Pharmaceutical innovation stems from a variety of sources. Practicing doctors and healthcare providers generate concepts and collect observational data for new and improved treatments using existing approved medication. Alternatively, university researchers study...
Nitrosamine risk evaluation and testing, what’s next?

Nitrosamine risk evaluation and testing, what’s next?

Nitrosamine compounds have long been considered probable human carcinogens. Nitrosamines are produced by the reaction of nitrites and secondary amines. Nitrosamine compounds are ubiquitous in food, beverages, and the environment. In 2018, angiotensin II receptor...