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Tag Archives: exclusivity
Therapeutics for Rare and Neglected Diseases – How Rare is Rare?
The U.S. National Institutes of Health (NIH) classifies a rare disease as affecting less than 200,000 individuals in the United States. As insignificant as this classification may sound, collectively there are more than 25 million people in the United States … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged analytical testing, biomarker, clinical trials, dos, exclusivity, FDA, IND, NIH, novel therapeutic, Orphan Drug Designations, tax credit, toxicology
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FDA Ups the Ante on Transparency
Transparency is not the same as looking straight through a building: it’s not just a physical idea, it’s also an intellectual one. – Helmut Jahn I’ve talked about its transparency initiative before (here, here, here, and here), but the FDA’s … Continue reading
Posted in FDA, Industry News
Tagged 510(k), ANADA, ANDA, biologics, BLA, drugs, exclusivity, FDA, medical devices, NADA, NDA, patent, PMA, transparency
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