Each year pharmaceutical companies must fulfill annual deadlines to become and remain compliant with the FDA. Each company responsible for submitting drug product listings, be they drug manufacturers or distributors, will have unique schedules 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. Most of these deadlines fall within the final quarter of the year; however, some may vary. It is also pertinent to consider that as the deadlines approach, FDA gets inundated with many submissions and their turnaround time could potentially increase causing your file to process after the due date. It is best to submit well before the applicable deadlines.
On Thursday, November 2nd, Reed Tech presented an educational webinar to learn more about these annual year-end FDA deadlines. Reed Tech subject-matter experts Gary Saner and Julia Frasch designed this webinar to help regulatory teams understand the best way to navigate these annual requirements and ensure they are complying with all year-end deadlines.
For more information about Year End Deadlines or new OTC Monograph Changes or MoCRA regulations, visit our resource page: Reed Tech.
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About LexisNexis Reed Tech
LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™️ for Medical Devices, SingleSource™️ for Drug Products, and Navigator™️ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.
For more information, please visit ReedTech.com
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