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Pursue Agreement with Indian Counterparts to Facilitate Communication and Collaboration
Description: Medical products Memorandum of Intent (MOI) with Ministry of Health and Family Welfare (MHFW): This agreement will clarify and facilitate better understanding with relevant counterparts on the purpose and areas of engagement with the India Office. This agreement, usually requested by Government of India (GOI) counterparts, enables communications and interactions to proceed without continued approvals by more senior Ministry officials. This agreement should bring the regulatory agencies closer and begin to build stronger relationships that should allow further sharing of information and possibly lead towards confidentiality agreements. Upon finalization of this agreement, the FDA will pursue better recognition and practice of U.S. regulations.
OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.
Briefing Status: COMPLETED
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
A. Draft developed by India Office |
9/1/2010 |
Completed | 9/1/2010 |
|
B. Submit to Centers for review/clearance |
9/15/2010 |
Completed | 9/15/2010 |
|
C. Submit to Office of the Chief Counsel (OCC) for review/clearance |
10/1/2010 |
Completed | 10/1/2010 |
|
D. Submit to India counterparts for review/clearance |
10/13/2010 |
Completed | 10/13/2010 |
|
E. Quarterly assessment of the status of GOI review/clearance |
12/31/2010 |
Completed | 12/31/2010 |
|
F. Quarterly assessment of the status of GOI review/clearance |
3/31/2011 |
Completed | 3/31/2011 |
|
G. Determine necessary follow up if comments not received |
6/30/2011 |
Completed | 8/5/2011 |
|
H. Revise plan/project as necessary |
7/31/2011 |
Completed | 7/12/2011 |
|
I. Resubmit to Centers to consider/react to proposed changes (1) |
N/A |
N/A | N/A |
|
J. Submit to OCC to finalize (1) |
N/A |
N/A | N/A |
|
K. Sign agreement (1) |
N/A |
N/A | N/A |
Footnotes
- (1) Milestones were not completed while this project was tracked in FDA-TRACK.
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.
