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Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: Stephen How who wrote (1019)	6/13/1998 11:31:00 PM
From: Stephen How	Read Replies (1) \| Respond to of 1432

"FDA to Ease Rules on 'Off-Label' Uses of Drugs, Devices." Wall Street Journal, 8 June 98, B6. The Food and Drug Administration is proposing new rules that would allow drug and medical-devices manufacturers to distribute studies published in scientific journals about the safety and effectiveness of using their products in ways not specifically approved by the FDA. Some consumer groups fear the new rules could expose people to unnecessary dangers, citing the "'phen-fen'" diet pill as an example. The FDA says the new rules will require companies to submit a copy of the information 60 days before distributing it. ------------ This sounds like a way that Dupont could effectively get US approval of Pentaspan&reg for use as a plasma expander. As I've posted before, Pentaspan&reg is only approved for leukapheresis in the US, while it has been an albumin replacement in Canada since 1993. Steve btim.dyn.ml.org