FOR IMMEDIATE RELEASE: May 1, 2017
Coté Orphan LLC
Coté Orphan Expands FDA Expedited Program Service Offering
The firm now offers Regenerative Medicine Advanced Therapy Designation submissions
Silver Spring, MD: Coté Orphan, a boutique full-service regulatory group, added Regenerative Medicine Advanced Therapy (RMAT) Designation submissions to the service offerings of the firm today.
The RMAT designation was created through passage of the 21st Century Cures Act, and is the latest expedited program for serious conditions at the U.S. Food and Drug Administration (FDA). Other examples of FDA expedited programs are: Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval and Priority Review.
This designation encourages the FDA to consider the appropriateness of accelerated approval for each RMAT therapy based on three qualifying criteria: Drug type, intention, and preliminary evidence. The drug must be defined as a regenerative medicine therapy (cell therapy, therapeutic issue engineering product, human cell and tissue product, or any combination product using such therapies or products) with the intention to treat, modify, or cure a life-threatening disease, and have preliminary evidence that the drug will address unmet medical need.
The benefits of the RMAT designation are similar to the FDA’s Breakthrough designation. This includes increased interaction with the FDA for expedited development and review of drugs, and possible eligibility for priority review and/or accelerated approval. The request for RMAT designation must be made either concurrently with the submission of an Investigational New Drug application (IND) or as an amendment to an existing IND. The FDA will produce a written response within 60 days, including reason for decline if necessary.
Coté Orphan helps companies navigate the FDA’s expedited approval pathways for serious conditions. Our regulatory staff are well-versed in the unwritten rules of the FDA, and have had great success helping our client’s products achieve breakthrough status, among other designations.
To contact our RMAT Business Development Manager and explore the possibilities of applying for and obtaining RMAT designation, contact 202.768.5258 or 202.768.3482.
About Coté Orphan: Coté Orphan is a boutique full-service regulatory group with a laser focus on Orphan Drugs and expedited approval pathways. From the lab to the market, we take your idea to the FDA and EMA for approval. With over 300 innovative biotechnology and pharmaceutical clients, Team Coté is led by Dr. Tim Coté, the former Director of the FDA’s Office of Orphan Products Development (OOPD).