Under the drug application process, a sponsor of a nonprescription drug submits a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) to FDA for approval. The sponsor cannot market the nonprescription drug until FDA approves the NDA or ANDA. One important difference between a drug application for a prescription drug and a nonprescription drug is that consumer behavior studies are often needed to demonstrate that consumers can use the nonprescription drug product safely and effectively without the supervision of a healthcare provider. The consumer behavior studies conducted by a sponsor of nonprescription drug typically include: label comprehension, self-selection, actual use, and human factors studies. FDA encourages all potential drug sponsors to initiate contact with the Office of Nonprescription Drugs (NDA products) or the Office of Generic Drugs (ANDA products) as early as possible, so that drug sponsors can consider FDA’s product development recommendations.