OHRP/FDA collaborate on smallpox vaccine clinical trials in children. (Regulatory Update).(Office for Human Research Protections)

Publication: Research Practitioner

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COPYRIGHT 2002 A Thomson Healthcare Company

The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) are soliciting public review and comment on a proposed research protocol submitted by Harbor-UCLA Medical Center titled, "A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age," as announced in the October 31, 2002, Federal Register. The National Institute for Allergy and...

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