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Biotech / Medical : ORTC Ortec International

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To: Rick Strange who wrote (258)	2/27/2000 11:30:00 AM
From: Lane Hall-Witt	Read Replies (1) of 272

Rick, Yes! Here's a statement, from the FDA Web site, on the provision for seven-year marketing exclusivity: "Section 527 of the Orphan Drug Act provides a seven-year period of exclusive marketing to the first sponsor who obtains marketing approval for a designated orphan drug or biological product. Exclusivity begins on the date that the marketing application is approved by FDA for the designated orphan drug, and applies only to the indication for which the drug has been designated and approved. A second application for the same drug for a different use could be approved by FDA." fda.gov This incentive, and others, are designed to encourage the development of treatments for very small medical markets -- markets that otherwise would be too small to generate the private-sector R&D that's needed to bring these treatments to market. For an introduction to the FDA Office of Orphan Products Development, see: fda.gov On the Humanitarian Device Exemption, which covers CCS, see: fda.gov Finally, here's a 1996 article that hints at the Rocky story: cpmcnet.cpmc.columbia.edu

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