Which agency requires drug manufacturers to perform bioequivalency studies prior to marketing?

The requirement for drug manufacturers to perform bioequivalency studies prior to marketing their products is mandated by the Food and Drug Administration (FDA). Bioequivalency studies are crucial for demonstrating that a generic drug product is comparable in terms of dosage form, strength, route of administration, quality, and intended use to a brand-name drug. This process ensures that the generic version is therapeutically equivalent and that patients can expect the same clinical effect and safety profile.

The FDA's role in regulating these studies is pivotal for maintaining drug quality and patient safety. By ensuring that generic drugs are bioequivalent to their brand-name counterparts, the FDA helps to facilitate competition in the pharmaceutical market, which can lead to lower drug prices and improved access for patients.