How does the FDA approve drugs?
The Food and Drug Administration (FDA) is charged with ensuring the safety and effectiveness of all prescription drugs marketed in the U.S. Before the FDA gives the drug manufacturer approval for marketing a given drug, it considers two primary points: whether the clinical trials provide substantial evidence that the drug is effective, and whether the drug is safe under the conditions outlined in labeling. Ultimately, what the FDA considers is whether the benefits of the drug outweigh its risks. For life-threatening diseases, the FDA has mechanisms that allow the approval process to be condensed so the treatment can be used and brought to market in an accelerated manner.
