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Missed FDA Annual Deadlines? It’s not too late to keep your drug active!

Jan 10, 2023 | Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics


The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year. 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 In fact, FDA has already begun to send out notices of intent to inactivate outdated drug listing records to some customers. These notices explain the drugs in question will become inactive by the end of January 2023.

Why is my drug becoming inactive? Companies that are receiving these notices have failed to update or certify no-changes for the previous calendar year. Often, this requirement is met with a blanket no-change certification that is due December 31st.

How to avoid inactivation? The good news, it is not too late to avoid inactivation! A new, updated drug listing must be submitted to FDA as soon as possible.  If the file is accepted, this will prevent the drug from becoming inactive. Contact [email protected] to learn how to create and submit your drug listing before it’s too late.

What if my drug is no longer being manufactured and distributed? These drug listings still need to be updated to be removed. These listings need to include a Marketing End Date so that it will be removed rather than inactivate.

To learn more about what action you need to take, watch this short video with Reed Tech subject-matter expert, David Wilson.

For help with your submissions or more information, contact Reed Tech at [email protected] or +1 (215) 557-3010.