Each year, regulatory teams must comply with several FDA year-end deadlines. Each company responsible for submitting drug product listings will have its own unique schedule for submission to FDA based on application approval dates and updates to labeling and listing information. However, FDA has established several specific reporting periods throughout the year for various electronic drug product submissions. These include Drug Sample Distribution Reports, GDUFA Self-Identification submissions, Establishment Registrations and No Change notifications for Drug Product Listings.
These deadlines are further explained in this Reed Tech authored article in BioPharma Dive: Achieve compliance through year-end pharma annual requirements.