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U.S. Department of Health and Human Services

About FDA

Orphan Drug Designation Standard Operating Policy and Procedure (SOPP)

Description: OOPD has developed over many years both written and unwritten internal policies and guidance to complement the regulations governing the approval of an Orphan Drug designation. Orphan Drug applications are becoming more complicated to review as a result of more complex drug development. Thus, OOPD is in need of establishing a single standard operating policy and procedure (SOPP) document that pulls together existing internal policy and procedural documents and also addresses emerging issues. The goal of this project is to continue to ensure internal consistency while addressing in a timely manner many new and challenging ideas by drug sponsors.

Accomplishment: A Standard Operating Procedure was developed and put into operation on November 9, 2010 by the Office of Orphan Products Development (OOPD) for the review of applications for orphan drug designation. This is an internal document. This document provides a standard form and a standard process for the review of a request for an orphan drug designation. The document ensures that the office continues to provide a consistent and quality review of requests submitted to OOPD for orphan drug designation. The document provides a template and disseminates to reviewers the standard policies followed by OOPD in making decisions regarding orphan drug designation.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Initiate SOPP development process


Completed 1/29/2010

B. Charge SOPP Committee


Completed 2/10/2010

C. Draft outline of needed designation SOPP


Completed 4/16/2010

D. Finalize and prioritize content outline of needed designation SOPP


Completed 6/17/2010

E. Issue assignments to draft individual SOPP sections


Completed 7/16/2010

F. Review draft SOPP sections


Completed 9/17/2010

G. Approve and implement SOPP for internal use


Completed 11/17/2010

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.


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.