NORD writes PhRMA
National Organization for Rare Disorders criticizes Pharmaceutical Research & Manufacturers of America for ads suggesting that without drug patents research on rare diseases would decline. "The exclusivity provision of the Orphan Drug Act precludes competition for seven years with a higher degree of certainty [than patents], and this has influenced hundreds of companies to invest in orphan drug research and development," NORD says in June 6 letter...
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The yet-to-be-named medtech company will focus on orthopedic implants and bracing and recovery devices.
Our infographic offers a composite sketch from a decade of US FDA data on refuse-to-file letters.