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HemaCare plans national clinical trials of Immupath. (passive hyperimmune therapy) (California)
DATELINE: California
HemaCare Corporation, Los Angeles, California, announced that at a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) on August 30, 1993, company representatives presented plans to conduct national clinical trials of Immupath, a bio-pharmaceutical product which applies the principle of passive hyperimmune therapy as a potential treatment for AIDS.
The discussion with the FDA covered the following areas: clinical trial design; plasma processing facility design and validation; licensure of plasma donation centers. …
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