Tag: Fda approval process

According to the FDA, the journey of a new drug from discovery to market can take over a decade and cost billions of dollars. This extensive process is defined by a series of rigorous stages designed to test for both safety and effectiveness. Understanding what are the 5 steps for FDA approval sheds light on the high standards required for new medications.

According to the Biotechnology Innovation Organization (BIO), only about 31% of drugs successfully transition from a Phase 2 clinical trial to a Phase 3 study. This high attrition rate underscores the critical importance of successfully navigating **What is FDA Phase 2?**, the pivotal stage focused on confirming a drug's effectiveness and refining its optimal use in patients.