Click here to read Coté Orphan’s comments to the FDA on Rare Pediatric Disease Review Vouchers. Coté Orphan was afforded the opportunity to submit comments on the Draft Guidance for Industry, “Rare Pediatric Disease Review Vouchers”, which was published on November 17, 2014.
Click here to read the full article in Medical Marketing & Media. The Maturing Rare-Disease Market Noah Pines, Writer Currently on the cusp of a seismic shift toward innovative, ultra-targeted therapeutics, the rare disease market continues to be dominated by small-molecule medications. Industry analysts have focused their thoughts on..
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Click here to read the article in Pharmaceutical Commerce. The Maturing Rare-Disease Market Suzanne Shelley, Contributing Editor As rare diseases have emerged as a market opportunity for pharma over the past several years, industry practices are beginning to stabilize. The Orphan Drug Act of 1983 (ODA) opened the..
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Coté Orphan‘s new Clinical Research Organization fortifies its foundation as a full-service industry leader in orphan drug regulatory affairs and development. Silver Spring, Maryland – Coté Orphan, LLC, a leader in orphan drug regulatory affairs, today announced the addition of a new line of service for its clients by providing..
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OrphanDB provides a contextual, single location for easy access to all up-to-date information on FDA and EMA Orphan Drug Designation Status Silver Spring, Maryland – 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..
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Coté Orphan Consulting (COC) and the ERA Consulting Group (ERA) are pleased to announce the establishment of a strategic transatlantic alliance to provide comprehensive services to clients developing products for orphan indications. Coté Orphan Consulting is a regulatory affairs advisory firm, led by Dr. Timothy Coté, former director of the..
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