01357nam 2200373Ia 450 991069911310332120230902162108.0(CKB)5470000002400769(OCoLC)466807023(EXLCZ)99547000000240076920091118d2005 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierReviewer guidance[electronic resource] conducting a clinical safety review of a new product application and preparing a report on the reviewRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,[2005]1 online resource (79 pages)"Good review practices.""February 2005."Reviewer guidance Clinical trialsReportingGovernment policyUnited StatesDrug approvalGovernment policyUnited StatesClinical trialsReportingGovernment policyDrug approvalGovernment policyCenter for Drug Evaluation and Research (U.S.)GPOGPOGPOBOOK9910699113103321Reviewer guidance3514523UNINA