Letter of Authorization (LOA) Request for Master File

To reference STEMCELL’s Master File in your FDA application, please complete this online request form for a Letter of Authorization (LOA). Please click “Submit” after completing all required fields(*). STEMCELL will contact you once we have reviewed and processed your request.

If you are located outside of the U.S., STEMCELL can work with you to provide Regulatory Support Files directly to your Regulatory Agency to support your submission. Please contact us here or via your local representative.

Application Number (i.e. IND, BLA, DMF)*

Application Title *

FDA Division (i.e. CBER, CDER, CDRH)*

Principal Investigator(s)*

Company/Sponsor Name *

Brief Description of Study *

Disease Indication *

Application Phase *

STEMCELL Product in Use *

Tentative FDA Application (IND, BLA, DMF) Submission Date *

How did you hear about us? *

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