Amarin Corp Plc (AMRN)

[Biobillionair]

Fast track designation applications:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
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Fast track designation requests should contain the following information (in most cases, this information could be captured in approximately 10 to 20 pages):
? If the fast track designation request is submitted to the sponsor’s IND as an amendment, identification of the submission in the cover letter as a REQUEST FOR FAST TRACK DESIGNATION in bold, uppercase letters. If the request is submitted with an initial IND, identification of the submission in the cover letter as both an INITIAL INVESTIGATIONAL NEW DRUG SUBMISSION and REQUEST FOR FAST TRACK DESIGNATION in bold, uppercase letters.
? In the cover letter of the submission, the name of the sponsor’s contact person and the contact person’s address, email address, telephone number, and fax number.
? If applicable, the IND application number.
? If available, for drug products, the proprietary name and active ingredient and for
biological products, the proper name and proprietary name.
? The division or office to which the IND is being submitted or in which it is active.
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? The proposed indication(s).
? A concise summary of information that supports the fast track designation request for the
indication being studied, including the following:
o The basis for considering the drug to be one intended to treat a serious condition
o The basis for considering the drug to have the potential to address an unmet medical need and an explanation of how this potential is being evaluated in the planned drug development program (e.g., a description of the trials intended to evaluate this potential)
? If applicable, a list of documents previously submitted to the IND that is considered relevant to the designation request, with reference to submission dates. Paper submissions can be resubmitted to FDA as appendices to the designation request.
4. FDA Response
FDA will respond to fast track designation requests within 60 calendar days of receipt of the request.
a. Designation letter
If the Agency determines that the criteria for designation as a fast track drug development program have been met, the designation letter will:
? State that fast track designation is granted for development of the product for use in treating the specific serious condition
? Point out that the sponsor should design and perform studies that can show whether the product meets an unmet medical need
? Alert the sponsor to the need for the drug development program to continue to meet the criteria for fast track designation
b. Nondesignation letter
If the Agency determines that a fast track designation request was incomplete or that the drug development program failed to meet the criteria for fast track designation, the Agency will send a nondesignation letter to the sponsor. The nondesignation letter will state that fast track designation is not granted and explain the reasons for the Agency's decision.
5. Continued Designation as a Fast Track Development Program
Over the course of drug development, it can be expected that some products granted fast track designation will not continue to meet the criteria for fast track designation. A drug product in a
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fast track development program may not continue to meet the criteria if the drug: (1) no longer demonstrates a potential to address unmet medical need or (2) is not being studied in a manner that shows the drug product can treat a serious condition and meets an unmet medical need. The drug product may no longer demonstrate a potential to address unmet medical need, for example, if a new product was approved under a traditional approval that addressed the same need or if emerging clinical data failed to show that the product in a fast track development program had the anticipated advantage over available therapy. For products in fast track drug development programs, the Agency expects that the appropriateness of considering particular drug development plans as part of the fast track program will be discussed and evaluated during the drug development process, including at the end-of-phase 2 meeting and the pre-BLA or pre- NDA meeting. If the sponsor recognizes that the fast track drug development program will no longer be pursued, the sponsor should inform the Agency of this change.
When fast track designation is no longer supported by emerging data or the designated drug development program is no longer being pursued, the Agency may choose to send a letter notifying the sponsor that the program is no longer designated as a fast track drug development program.