Post-marketing drug monitoring

In the wake of the AIDS crisis in the 1980s, the US Food and Drug Administration responded to critics of its slow approval process by introducing the first of their expedited approval processes – Accelerated Approval, writes Dr Nicola Davies in her monthly exclusive article for The Pharma Letter.

In order to appease AIDS activists and lobbyists for a freer drug market, this process allowed drugs that were created to treat life-threatening diseases to reach markets quicker, as long as there were no viable approved alternatives already available. Eventually, three other processes to accelerate approval were put into place by the government – Fast Track, Priority Review, and the Breakthrough Therapy designations.

Which drugs get expedited approval?