How to Handle Missed

Year-End Deadlines 

(and OTC Monograph Exceptions)


Recorded on February 21, 2024 at 2 PM ET

The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year to remain compliant. Most of the deadlines fall on December 31st. What happens if a manufacturer misses these deadlines? In most cases, the drug is in danger of becoming inactive. In fact, FDA has already begun to send out notices of intent to inactivate outdated drug listing records to some companies. These notices explain the drugs in question may have already become inactive by the end of January 2024.

Don’t worry, you can still get back on track and Reed Tech can help! On Wednesday, February 21, 2024, Reed Tech presented a webinar explaining what to do if you fear you may have missed a year-end deadline. Subject-matter experts Gary Saner and Julia Frasch explain how to determine if a deadline was missed, what steps to take and how the 2023 over-the-counter monograph changes affect your ability to submit a late Blanket No-Change Certificate. 

Watch the recording now!

For more information about Year End Deadlines or new OTC Monograph Changes or MoCRA regulations, visit our resource page: Reed Tech.

More questions? Contact or +1-215-557-3010.

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.

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