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Biotech / Medical : SANGUINE CORP. (SGNC)
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To: Mongo2116 who wrote (2552)7/5/1998 1:19:00 AM
From: chirodoc  Read Replies (2) of 5402
 
HEY GUYS/GALS, LOOK AT THIS!

THE FEDERAL GOV. (FDA) HAS ALREADY PUBLISHED GUIDELINES FOR USE IN EVALUATING THE EFFICIENCY OF PERFLUOROCARBONS!

hint: that means they expect lots of studies on pfc's--would they do this for a highly toxic substance?

"Draft ''Guidance for Industry: Efficacy Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers;'"

September 8, 1997 (Monday)

[Federal Register: September 8, 1997 (Volume 62, Number 173)]
[Notices]
[Page 47212-47213]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se97-49]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 90N-0349]
Draft ''Guidance for Industry: Efficacy Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ''Efficacy Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen Carriers.'' The document is intended as general guidance for manufacturers, investigators, sponsors, and other parties interested in the design, endpoints, and efficacy criteria for clinical trials of hemoglobin- and perfluorocarbon-based oxygen carrier products.
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