Drug Regulatory Affairs & regulations on orphan drugs EU and US

Topic: Drug Regulatory Affairs & regulations on orphan drugs EU and US

Order Description
Describe the evolution of the regulations on medicines for rare diseases (orphan drugs) in both the USA and the EU.
Point out the differences between the two sets of regulations and how these may offer advantages or be a disadvantage to companies developing these medicines.
Word limit 800 to 1200 excluding tables and references.
Number of internet sources are unlimited but preferably use the website in the documentation attaches.