About FDA
Optimize Legal, Regulatory and Policy Framework
Description: Modernize and optimize the legal, regulatory, and policy framework for efficient preparedness and response by assessing current laws and regulations and proposing changes that will facilite an efficient response to public health emergencies.
Briefing Status: ON TRACK
Prior Briefing Status: ON TRACK
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
|
1. Establish a legal and policy team (EPIC--Emergency Use Authorization (EUA) Policy Implementation Committee) to review and analyze current laws and regulations and recommend changes |
12/31/2010 |
Completed | 1/6/2011 |
|
2. Draft chapter on the medical countermeasures "FDA Emergency Preparedness and Response Roles and Authorities" for inclusion in a publication being issued by the Food and Drug Law Institute (FDLI), Food and Drug Law and Regulation Book |
6/1/2011 |
Completed | 6/13/2011 |
|
3. Propose to the Department changes to FDA's authorities to facilitate MCM availability as part of the Department's legislative package for reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). Revisions would allow FDA to issue EUAs in advance of a CBRN event, facilitate mass dispensing of approved products and authorize shelf-life extension. |
6/30/2011 |
Completed | 6/1/2011 |
|
4. Develop and issue doxycycline mass dispensing EUA |
5/30/2012 |
Completed | 7/21/2011 |
|
5. Develop and issue doxycycline USPS EUA for Cities Readiness Program |
7/30/2012 |
Completed | 10/14/2011 |
Footnotes
- Additional milestones are currently under development.
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.
