Accelerated approval process

The accelerated approval process is a method used by regulatory agencies, like the FDA, to get promising medicines to patients more quickly. It allows approval based on early evidence that a drug may be effective, especially for serious or life-threatening conditions. This process often relies on surrogate endpoints—indirect measures linked to clinical benefit—to speed up access. However, manufacturers must conduct further studies after approval to confirm the drug’s effectiveness and safety. This approach balances the urgent need for new treatments with ongoing responsibility to ensure they truly work and are safe for patients.