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U.S. Department of Health and Human Services

About FDA

Improving the Generic Drug Review Process and Review Queue Management

Description:
This key project has been retired as CDER has created new measures and key projects for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

A. Develop an Understanding of the Current State

Briefing Status: Completed

Prior Briefing Status: Completed

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Document the current state of review management within the Office

9/15/2010

Completed 9/15/2010

2. Draft a segmentation methodology for applications in the queue

9/15/2010

Completed 9/15/2010

3. Document the findings from internal FDA interviews

9/15/2010

Completed 9/15/2010

B. Develop an Improvement Assessment

Briefing Status: Completed

Prior Briefing Status: Completed

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Document the overall improvement process

10/15/2010

Completed 10/15/2010

2. Determine impact of process improvements and queue management on the overall review queue

10/15/2010

Completed 10/15/2010

3. Draft a plan for internal communication

10/15/2010

Completed 10/15/2010

C. Finalize Recommendations

Briefing Status: Completed

Prior Briefing Status: Completed

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Deliver final toolkit for process improvements and queue management

1/1/2011

Completed 1/1/2011

D. Implementing the Recommendations from McKinsey

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Complete response

N/A

N/A N/A

a. Letter – drafted in clearance

1/1/2012

On Track

b. Public Communication – drafted in clearance

1/1/2012

On Track

c. Standard procedure for use of letter – in progress

1/1/2012

On Track

2. Dashboard for project managers to TRACK ANDA review process

N/A

N/A N/A

a. Develop database tool – Done; review flow system

6/13/2011

Completed 6/13/2011

b. Roll-out across OGD – 100% complete

10/1/2011 6/1/2012

On Track

3. Implement more stringent filing criteria

N/A

N/A N/A

a. Develop revised criteria

1/1/2011

Completed 6/1/2011

b. Public communication – on website

1/1/2012

Completed 6/1/2011

4. Quality Management System

N/A

N/A N/A

a. Develop list of needed IQPs

10/18/2010

Completed 10/18/2010

b. Train staff on IQPs – on going

 

c. Audits – OPS-wide audit

12/31/2011

Completed 2/14/2012

5. Separate DMF review from Chemistry

N/A

N/A N/A

a. Establish DMF review team

 

Completed 4/1/2011

b. Establish process for DMF review management - Drafted

1/1/2012

On Track

c. Audits – OPS-wide audit

12/31/2011

On Track

6. Count the number of complete response letters issued – initiate tracking 2012

10/1/2012

7. Percentage of completed IQPs versus number of needed IQPs

33% as of September

8. Percentage of staff trained on IQPs – 95% of staff needing particular training are trained

12/31/2011

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.