We now know that recovery from injury or disease involving inflammation, is complex. While inflamed tissues have many causal factors and complex biological interactions, the result is that the balance has been shifted from health to dysfunction. This calls for a novel approach to therapeutics – a ‘paradigm shift’.
New drugs approved by the FDA and other regulatory bodies have a long path to approval that requires toxicology studies to prove safety, detailed evidence of safe delivery and effectiveness, with a very large body of documentation to establish manufacture and stability. An already approved drug that is repurposed (used to treat another disease) has a considerably truncated route to FDA approval.