Orphan Drug Designations

Our flagship service. We write orphan drug designation (ODD) applications for both the FDA and EMA. Obtaining ODD entitles the sponsor to economic benefits which vary depending on whether it is the FDA, EMA, or both (recommended).

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Regulatory Strategy

No matter where you are in your orphan drug development process, we can assess your program and bring a sound regulatory strategy to help expedite achieving your goals and ensure you are using all the regulatory perks at your disposal.

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Meetings with the FDA
(pre-IND, Type A, B, C)

From the pre-IND meeting to the pre-NDA/-BLA, you will meet with the Agency to gain insight into their thinking about your drug development. We know how to optimize these meetings so that you can get the most out of FDA resources that are accessible to drug developers.

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Prior to first-in-human studies, you must file an IND with FDA to demonstrate that it is safe to use your drug. After being informed by a pre-IND meeting, we will review and analyze and write your IND for submission to the Agency.

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Submissions for Expedited Programs

o Breakthrough Therapy Designation
o Fast Track Designation
o Accelerated Approval
o Priority Review Voucher

The FDA’s expedited programs are designed to accelerate the development of certain drugs.  Breakthrough Therapy, Fast Track, and Priority Review all require designation to obtain their incentives which Only Orphans Cote can help with. Accelerated Approval, on the other hand, allows a sponsor to gain approval on a surrogate endpoint. We can also assist with the preparation for your meetings to obtain approval on utilizing a surrogate endpoint.

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Additional Services and Programs

o Qualified Infectious Disease Program (QIDP) Designation
o 505(b)(2)

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+1 617-852-6416
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