Tag: Real world evidence

Hundreds of thousands of clinical studies are conducted worldwide each year. While a drug's approval is a major milestone, it is not the final step. So, **what is phase 4 of the drug development process?** This critical stage, also known as post-market surveillance, begins after a drug is approved and made available to the public.

A study of 222 novel drugs approved by the FDA found that nearly a third (32%) were affected by a postmarket safety event, highlighting the importance of post-approval monitoring [1.9.3, 1.9.4]. So, what does phase 4 of drug development focus on after a medication is already on the market?