18 March 2013

FDA Drug Approval Process

FDA approval process

If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials:
  • Phase 1 uses 20-80 healthy volunteers to establish a drug's safety and profile. (about 1 year) 
  • Phase 2 employs 100-300 patient volunteers to assess the drug's effectiveness. (about 2 years) 
  • Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)
The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half 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.
The research-based pharmaceutical industry currently invests some US$12.6 billion a year in new drug development. Historically, the drug development figure doubles every five years.

See also: How Drugs are Developed and Approved
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