ABSTRACT
The holders of new drug applications and abbreviated new drug applications can make postapproval changes in accordance with added section 506A of the Food and Drug Administration Modernization Act. A drug made with a manufacturing change, whether a major manufacturing change or otherwise, may be distributed only after the holder validates the effects of the change on the identity, strength, quality, purity, and potency of the product as these factors may relate to the safety or effectiveness of the product. An assessment of the effect of a change on the identity, strength, quality, purity, or potency of the drug product should include a determination that the drug substance intermediates, drug substance, in-process materials, or drug product affected by the change conforms to the approved specifications. A drug product labeling change includes changes in the package insert, package labeling, or container label.
