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98N-0237: New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
Item Code
No.
Received Date
Submitter
Signature
FR Date
FR Page
PDF ID
(Size KB)
Text ID
(Size KB)
NFR 1             05/31/02 37988 pdf txt
C 5 05/14/01 NIH/Deputy Director of Management Anthony L Itteilag        pdf    
C 4 05/14/01 NIH/Office of Protection from Research Risk Gary B Ellis, PhD         pdf    
NAL 1             01/18/00 2633 pdf txt
SS 1 01/14/00 Supporting Statement             pdf    
C 3 01/13/00 McGill University Imre Szebik MD MSc         pdf    
C 2 01/04/00 CSL Research and Development Lorraine Beezum        pdf    
C 1 12/20/99 EluXyx Therapeutics Inc Linda Nordone PhD RAC         pdf    
BKG 1 10/04/99 Background Material                 htm
NPR 1            10/05/99 53960 pdf txt

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Page last updated March 9, 2004

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