The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records. This action is not limited only to listings for finished drug products, but also for active pharmaceutical ingredients and other unfinished drugs.
The human drug listings that were not certified in the previous renewal period of October 1 to December 31 will be inactivated on September 12, 2019 and then every January. Additionally, every July thereafter, FDA will begin to inactivate human drug listings that remain active and certified after the June listing update, but still contain at least one establishment that is not currently registered in accordance with FDA’s requirements.
The agency strongly encourages companies to review and update inaccurate active drug listing submissions and establishment registrations as soon as possible in order to comply with the regulation requirements.
Asphalion has a broad experience with drug listing and establishment registration SPLs and their submission to FDA. In case you seek a support related to the SPL generation, please contact us at [email protected].