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Food and
Drug Administration
June 9 and 10, 2008
BRIEFING INFORMATION
Cover Memo (pdf)
PES AGenda Overview (pdf)
Overview Subpart D (pdf)
FDA Corticosteriod Guidance (pdf)
HIV Vaccine Case (pdf)
Asthma Trial Case (pdf)
Prospect of Direct Benefit (pdf)
Stem Cells and HIE Case (pdf)
FDA ICH E10 Choice of Control Group (pdf)
FDA IC H E11 Clinical Investigations in Pediatrics (pdf)
FDA Subpart D FR (pdf)