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 Description | Milestone Date | Milestone Status | Milestone 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 Description | Milestone Date | Milestone Status | Milestone 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 Description | Milestone Date | Milestone Status | Milestone 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 Description | Milestone Date | Milestone Status | Milestone 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 Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - 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.
