In Brief: ICH Good Clinical Practices draft guideline
ICH Good Clinical Practices draft guideline: Availability announced by FDA in the Aug. 17 Federal Register. The draft guideline, which reached step 4 of the International Conference on Harmonization process in May, is intended "to provide a unified standard for designing , conducting, recording and reporting trials" ("The Pink Sheet" May 29, p. 10). FDA is seeking comments on the draft guideline that should be addressed to the agency's docket number 95D-0219 by Oct. 2...
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