http://www.fda.gov/ForIndustry/DevelopingProd...24
Post# of 30067
Posted On: 10/16/2014 9:36:49 AM
http://www.fda.gov/ForIndustry/DevelopingProd...240819.htm
What is the review process like once application is received in OOPD? How is a designation application reviewed in OOPD? Please describe the review process for a designation application.
Following receipt of the Orphan designation application, the OOPD review process is as follows: The application is assigned a designation application number and logged into OOPD database and an acknowledgement letter is sent to the sponsor. The assigned OOPD reviewer completes the review of theapplication by preparing a review. The review is forwarded to the OOPD Team Leader for a second level review and concurrence. The review is forwarded for a 3rd level review by the OOPD Office Director. Following the OOPD Director’s concurrence, a designation letter, a letter requesting additional information, or a denial letter is prepared for the Director’s signature and the letter is issued to the sponsor.
http://www.fda.gov/ForIndustry/DevelopingProd...240819.htm
What is the review process like once application is received in OOPD? How is a designation application reviewed in OOPD? Please describe the review process for a designation application.
Following receipt of the Orphan designation application, the OOPD review process is as follows: The application is assigned a designation application number and logged into OOPD database and an acknowledgement letter is sent to the sponsor. The assigned OOPD reviewer completes the review of theapplication by preparing a review. The review is forwarded to the OOPD Team Leader for a second level review and concurrence. The review is forwarded for a 3rd level review by the OOPD Office Director. Following the OOPD Director’s concurrence, a designation letter, a letter requesting additional information, or a denial letter is prepared for the Director’s signature and the letter is issued to the sponsor.
http://www.fda.gov/ForIndustry/DevelopingProd...240819.htm
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