Timothy R. Coté, MD, MPH (Principal & CEO of Coté Orphan) Pediatric Rare Disease Priority Review Voucher In recent months industry talk has been extensive regarding the Pediatric Rare Disease Priority Review Voucher. These vouchers have been earned by developers of drugs for pediatric rare diseases and gives them..
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Click here to read the article in Medical Marketing & Media. Rare Diseases Target Practice Frank Celia, Writer An already-escalating orphan-drug market received an added lift when President Obama, in his State of the Union address in January, announced plans to finance a Precision Medicine Initiative with $215 million in..
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Timothy R. Coté, MD, MPH (Principal & CEO of Coté Orphan) You may ask “Unwritten Rules” what does that mean. The Unwritten rules are recognized as rules that are not available for public comment except in the occurrence that the director happens to mention them at an open forum or..
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Read Dr. Tim Coté‘s thoughts on the “Unwritten Rules” and “Written Rules” of Orphan Designation. The Unwritten Rules of Orphan Designation WP Dr. Coté defines the “Unwritten Rules” and Written Rules” of Orphan Designation based upon his experience as the former Director of the Office of Orphan Products Development. He..
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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 Coté Orphan was afforded the opportunity to submit comments on the Draft Guidance for Industry, “Rare Pediatric Disease Review Vouchers”, which was published on November 17, 2014.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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