The FDA or Food and Drug Administration is the body that approves all new drugs that are sold in the United States.
The Food and Drug Administration regulates the drugs that are sold in the United States. Before a new drug can be brought to market, it must meet the FDA standards for proof of safety and effectiveness.
For a new drug this typically involves the assembly of pre-clinical data, the submission of an Investigational New Drug Application (INDA) and the conduct of multiple human trials. These trials are referred to by their phases.
Phase II trials are used to make an initial finding of efficacy for the new drug. If the Phase II trials are successful then the drug will be advanced to Phase III.
Phase III trials are used to establish that a new drug is effective up to scientific standards of statistical significance. The FDA typically requires two successful phase III trials before approving a drug for sale to the public.
When the drug developer believes that the FDA's requirements have been met the results are submitted as a New Drug Application (NDA).
The FDA then takes a number of months to review the application. Prescription Drug User Fee Act (PDUFA) prescribes the time frame in which the FDA is required arrive at its decision. This act also requires the applicant to pay the cost of the evaluation.
Related Fool Articles
- The FDA's Call for Cash -- the agency seems to be underfunded these days.
- Does Leadership Count at the FDA? -- a look at the drug approvals under different FDA commissioners.
Related Community Blogs
Recent Mentions on Fool.com
- The Most Important Number in Gilead Sciences' Earnings Report
- Tougher Marijuana Regulations Could Be Coming to a State Near You
- The Blockbuster Potential of Biogen Inc's Pipeline
- Is This High Risk/High Reward Biotech Stock a Buy?
- 5 Can't-Miss Quotes From Gilead Sciences Management
- Still Profitless in Seattle Genetics