What does SNDA stand for?

The term SNDA stands for Supplemental New Drug Application. This involves the submission of additional information or changes to an already approved drug application. The purpose of an SNDA is to seek approval for modifications such as new indications, changes in dosage form, changes in labeling, or the introduction of new manufacturing processes that could affect the safety and efficacy of the drug.

Understanding the correct terminology is crucial in the field of pharmacy and drug regulation, as it reflects the ongoing processes by which pharmaceutical companies provide new data to regulatory bodies like the FDA to ensure that drugs on the market remain safe and effective for consumers. The term "Supplemental" specifically indicates that this application builds upon existing drug approval, distinguishing it from other types of applications that may not have the same foundational context.