Introduction
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
The Office of Pharmaceutical Science (OPS) is an integral part of the FDA Center for Drug Evaluation and Research (CDER) new and generic drug product application review process. The office provides uniform policies and review processes for the pharmaceutical industry.
In the area of new drugs, OPS reviews the chemistry components for new drug applications. On the generic side, OPS has the entire program, with the exception of inspections. The OPS laboratory programs support efforts to determine the correct quality standards, and in certain cases, validate the information companies provide.
