When new drugs are approved, the marketing authorization holders often have to commit themselves to perform additional post-authorization studies. These studies have a different set up. Most countries have adjusted the regulations for studies where the drug is commercially available; although there is no "one fits all" concept.
21st Century Cures Act and Real-World Evidence
THE INSIGHT SERIES: Do Late Phase Studies Offer Any Scientific Value? – Part 2
The growing focus on post-marketing and observational research has brought a heightened awareness, and scrutiny, on the design and execution of these…