Letter of Authorization (LOA) Request for Master File
To reference º£½ÇÆÆ½â°æâ€™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(*). º£½ÇÆÆ½â°æ will contact you once we have reviewed and processed your request.
If you are located outside of the U.S., º£½ÇÆÆ½â°æ 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.