New Drug Approval Process

1. New Drug Approval Process FDA Approvals

3. It takes 12 years and over $350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes 3 ½ of laboratory testing, Then an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only 1 in 1000 of the compounds that enter laboratory testing ever make it to human testing.

5. If the FDA gives the green light, the "investigative" drug enters three phases of clinical trials.

6. Phase 1 Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. Phase 1 lasts about 1 year 

8. Phase 2 • Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. • Phase 2 lasts about 2 years

10. Phase 3 • Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. • Phase 3 lasts about 3 years

11. Next step • The company then submits an application (usually about 100,000 pages) to the FDA for approval • The application process can take up to 2 ½ years. • After final approval, the drug becomes available for physicians to prescribe. • At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA.

12. Money, money, money, money • The research-based pharmaceutical industry currently invests $12.6 billion per year in new drug development. • Historically, the drug development figure doubles every 5 years.

16. References • Retrieved from http://www.drugs.com/fda-approval-process.html on 3/27/09