Drug Master Files, manufacturer listings, and Electronic Common Technical Document (eCTD) submissions are foundational to regulatory compliance. Yet even experienced regulatory, quality, and operations...
The global Unique Device Identification (UDI) landscape is entering a critical enforcement phase — and 2026 will be a challenging year for medical device manufacturers operating in the European Union...
The FDA’s final rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” establishes a uniform 12-digit format for FDA-assigned National Drug Codes (NDCs) ...
UDI product data is now due for specific scenarios (enforced as of December 8, 2022). Class I and Unclassified medical devices that are required to be labeled with a UDI code must submit product data...
LexisNexis Life Sciences Solutions and ONIX expand strategic alliance to guide pharma customers to market faster Professionals in the life sciences industry rely on unique regulatory affairs expertise...
The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year, with most deadlines falling on December 31st. When a manufacturer misses these deadlines, the drug is at risk of becoming inactive. The FDA has sent notices of intent to inactivate outdated drug listing records, explaining that affected drugs would become inactive by the end of January 2025.
Why is my drug becoming inactive? Companies receiving these notices have failed to update or certify no-changes for the previous calendar year. This requirement is typically met with a blanket no-change certification due December 31st.
How to avoid inactivation? It is not too late to avoid inactivation — or correct the situation if your product has already become inactive. A new, updated drug listing must be submitted to the FDA as soon as possible. LexisNexis Life Sciences can help you create and submit your drug listing quickly and accurately.
What if my drug is no longer being manufactured and distributed? These drug listings still need to be updated before they can be removed. Listings must include a Marketing End Date so the record is properly removed rather than inactivated.
To learn more about what action you need to take, watch this short video with LexisNexis Life Sciences subject-matter expert Julia Frasch.
Contact us