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U.S. Department of Health and Human Services

About FDA

Implement new ANDA labeling change provisions

Description: Implement processes and procedures to ensure that abbreviated new drug applications (ANDAs) with outdated labeling can be approved in the reference listed drug labeling was changes within 60 days of the event that cleared the way for generic competition and the generic sponsor agrees to submit a revised label within 60 days.

Accomplishment: Prior to passage of the Affordable Care Act (ACA), approvals of Abbreviated New Drug Applications (generic drugs) approvals could be delayed if the sponsor of the reference listed drug (RLD), the approved drug product to which new generic versions are compared to show that they are bioequivalent, made a change to the RLD label shortly before the generic drug approval. The Center for Drug Evaluation and Research (CDER) Office of Generic Drugs (OGD) has completed their requirements under the ACA. OGD implemented revisions to the Abbreviated New Drug Application (ANDA) approval letter ensuring that ANDAs with outdated labeling can be approved, if the RLD was changed within 60 days of the event that cleared the way for generic competition. In instances when this revised ANDA approval letter is issued, the generic drug sponsor must agree to submit a revised label within 60 days. This specialized approval letter will not be used if the changes to the RLD label were related to certain safety information. OGD has also developed a Manual of Policy and Procedure which has been put into place to assure a consistent application of the new provision and to track its use.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Draft revisions to the ANDA approval letter so that when necessary, the letter can serve as the notification of a labeling change to the reference listed drug

10/29/2010

Completed 10/29/2010

B. Implement changes to the Document Archiving, Reporting and Regulatory Tracking System (DARRTS) database to allow tracking of post-approval commitments to revise a generic drug's label

11/30/2010

Completed 11/30/2010

C. Draft a Manual of Policy and Procedures (MaPP) for the Office of Generic Drugs to describe the processes used to ensure Sec. 10609 of the Affordable Care Act is implemented fully

12/31/2010

Completed 12/22/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.