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U.S. Department of Health and Human Services

About FDA

A. Quality by Design (QbD) Road Map - Develop an understanding of the current state (1)

Accomplishment: The Office of Generic Drugs engaged the services of an outside contractor to assist with assessment of the current state in the Office with full documentation of findings and suggestions for review management and mechanisms for segmentation. The external group made several suggestions for improvement of the review process with projections on the impact those improvements would have. The recommendations were finalized, presented to OGD and to key managers in the Center. Work is underway to generally adopt those recommendations.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Document the current state of QbD within the Office

9/15/2010

Completed 9/15/2010

2. Document Office QbD metrics

9/15/2010

Completed 9/15/2010

Footnotes

  • (1) Impacts the CDER Office of Biotechnology Products (OBP) and the CDER Office of New Drug Quality Assessment (ONDQA)

B. Quality by Design (QbD) Road Map - Develop a comprehensive 2-3 year implementation roadmap (1)

Accomplishment: The Office of Generic Drugs engaged the services of an outside contractor to assist with assessment of the current state in the Office with full documentation of findings and suggestions for review management and mechanisms for segmentation. The external group made several suggestions for improvement of the review process with projections on the impact those improvements would have. The recommendations were finalized, presented to OGD and to key managers in the Center. Work is underway to generally adopt those recommendations.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Document the overall QbD implementation roadmap

10/1/2010

Completed 10/1/2010

2. Determine resources needed for implementation

10/1/2010

Completed 10/1/2010

3. Draft a plan for internal communication

10/1/2010

Completed 10/1/2010

Footnotes

  • (1) Impacts the CDER Office of Biotechnology Products (OBP) and the CDER Office of New Drug Quality Assessment (ONDQA)

C. Quality by Design (QbD) Road Map - Implement QbD Road Map Steps (1)

Briefing Status: Completed

Prior Briefing Status: Not Yet Started

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Report on early results of efforts versus implementation plan

6/1/2011

Completed 6/1/2011

2. Deliver communications materials

6/1/2011

Completed 6/1/2011

Footnotes

  • (1) Impacts the CDER Office of Biotechnology Products (OBP) and the CDER Office of New Drug Quality Assessment (ONDQA)

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.