ABSTRACT
The holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) can make postapproval changes in accordance with added Section 506A of the FDA Modernization Act. There are specific reporting requirements for postapproval changes in components and composition, manufacturing sites, manufacturing process, specifications, package labeling, miscellaneous changes, and multiple related changes. Reporting categories for changes relating to specified biotechnology and specified synthetic biological products regulated by the Center for Drug Evaluation and Research (CDER) are found in the guidance for industry entitled
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
(July 1997). Information specific to products is developed by an applicant to assess the effect of the change on the identity, strength (e.g., assay, content uniformity), quality (e.g., physical, chemical, and biological properties), purity (e.g., impurities and degradation products), or potency (e.g., biological activity, bioavailability, bioequivalence) of a product as they may relate to the safety or effectiveness of the product.
