How FDA Assures Generic Drug Quality
FDA's first eight steps of the generic review process are identical to the NDA process. Bioequivalence requirements for ANDAs are the same as NDAs. FDA's experience with drug products assures quality. FDA staff continually review published scientific literature. Generic companies read this literature and look at data from FDA.
More than half of all generic products on the market are corporately tied to brand companies. Multi-national companies make their own generics. Big company or small, new drug or generic, the drug product must meet all FDA approval criteria. Once the drug is approved, the same rules and regulations are in effect for both brand and generics.
FDA realizes that consumers do not fully understand the concept of bioequivalence. In the United States the term "generic" is not very positive. FDA has been mandated by Congress to educate people that these drugs may be generic, but they have the full weight of the FDA approval process behind them.