Coté Orphan Launches Mobile Application That Transforms Information Access To FDA and EMA Orphan Drug Status

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OrphanDB, the new mobile app by Coté Orphan, provides a contextual and single location for easy access to all up-to-date information on FDA and EMA Orphan Drug Designation Status.

OrphanDB Home Screen

"We are excited to release this free mobile app to market that transforms what was once a laborious and time-intensive process to search for the most relevant information on orphan drug status designation,” said Dr. Coté.

Coté Orphan, LLC, the leader in orphan drug regulatory affairs, today announced the launch of OrphanDB, its first mobile app designed to provide industry leaders a single source of truth to all FDA and EMA orphan drug status through a simple search. This complimentary mobile app, available for download using iOS and Android devices, will be the first of its kind to provide a user-friendly method of searching for orphan drug designation status in a matter of seconds.

OrphanDB allows users to easily access orphan drug designation information with both the Food & Drug Administration (FDA) and the European Medicines Agency (EMA) in one location, saving time navigating numerous databases and with the confidence the information curated for users is relevant and up-to-date.

Features include:

  • Granular search for orphan drugs matching criteria such as disease, active compound, trade or generic name, sponsor company, and even auto-suggest on partial entries
  • Immediate access to more detailed information from the FDA or EMA on a specific orphan drug designation submission, such as approval status
  • Configurable push notifications that allow users to follow the status of any orphan drug

Dr. Timothy Coté, CEO of Coté Orphan, LLC, recently serving as the Director of the FDA’s Office of Orphan Product Development, is utilizing more than two decades of experience and knowledge in the orphanology field to help bring clarity and simplicity to orphan drug product development and designation.

“We are excited to release this free mobile app to market that transforms what was once a laborious and time-intensive process to search for the most relevant information on orphan drug status designation,” said Dr. Coté. “This is another step in Coté Orphan’s continued quest to demystify the regulatory process and challenges inherent to orphan product designation.”

“Information changes rapidly in orphan product development, and users expect to receive relevant, contextual information in seconds on any device, at any time,” said Stephanie Daly, Director of Marketing for Coté Orphan. “OrphanDB utilizes the 20-plus years of experience of Dr. Coté and his team to curate the orphan drug search experience so that users can rest assured they are getting the information they need instantly.”

Coté Orphan will demo OrphanDB at upcoming industry conferences including the Rare Diseases and Orphan Products Breakthrough Summit in Alexandria, VA, BIO-Europe in Frankfurt, and World Orphan Drug Congress in Brussels. For more information, please visit http://www.coteorphan.com.

About Coté Orphan, LLC
Coté Orphan, LLC, a regulatory affairs advisory firm based in Silver Spring, MD, provides valuable strategic planning and execution services to companies developing or seeking to develop orphan drugs. Under the leadership of Dr. Timothy R. Coté, an orphanology expert and former Food and Drug Administration (FDA) Director for the Office of Orphan Products Development (OOPD), Coté Orphan demystifies the FDA regulatory process. Coté Orphan knows the FDA hurdles unique to orphan products and forges successful pathways to orphan product designation. For more information on Coté Orphan, please visit http://www.coteorphan.com.

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Stephanie Daly
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