Abstract

Post-approval activities are equally important throughout the lifecycle of a product. After got the approval of Abbreviated New Drug Application (ANDA) a product need to go through processes like submission of Final content of labeling, Electronic Drug Registration and Listing, Pharmacovigilance activities like ADER, FAR, PAS for any changes in the approved drug product for undisturbed and smooth commercial distribution of product.FDA have it own guidance and CFR for all these activities. Post-approval requirements for marketing applications, and requirements for the production of commercial products, are similar for products approved under either a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA).

Keywords: Food and drug administration (FDA); Abbreviated new drug application (ANDA); Adverse drug experience reports (ADE); Field alert reports (FARs); Prior-approval supplement (PAS); Code of federal regulation (CFR); National drug code (NDC); New drug application (NDA); Changes being effected (CBE)