Safety Evaluation of Generic Drug

For a New Drug Application (NDA) drug Safety and Efficacy must be established. This often requires a randomized clinical trial. According to the FDA, all drugs, including brand-name and generic drugs, must be effective and safe. Generic drugs use the same active ingredients as brand-name drugs and therefore have the same risks and benefits. However, some generic drugs may be stronger or weaker than the drugs they mimic, release the dose into the bloodstream incorrectly, or contain impurities-sometimes with dangerous effects. To ensure quality, safety, and effectiveness, the FDA conducts a thorough review process for all generic drugs, including a review of scientific information about the generic drug's ingredients and properties. In addition, the FDA requires that generic drug manufacturing facilities meet the same high standards as brand-name drug facilities.