ABSTRACT
Regulatory submissions refers to applications providing data or information to the Food and Drug Administration (FDA) related to the development, approval, or postapproval reporting for prescription drugs, biologics, and medical device products. Regulatory submissions are the primary means by which the pharmaceutical and the medical device industry communicate product-specific information to the FDA. Submissions of applications for either premarket investigations or market authorization are generally a series of submissions reflecting product or applicant information from the development stage throughout the marketing life cycle of a product.
