01472nam 2200409Ia 450 991069895370332120090702163343.0(CKB)5470000002398338(OCoLC)421145696(EXLCZ)99547000000239833820090702d2001 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] submitting marketing applications according to the ICH-CTD format, general considerationsRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :Center for Biologics Evaluation and Research,[2001]13, 1, 2 pages digital, PDF fileTitle from PDF title page (viewed on July 2, 2009)."Procedural"."August 2001".Guidance for industry Drug approvalDrugsMarketingClinical trialsReportingDrug approval.DrugsMarketing.Clinical trialsReporting.Center for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOBOOK9910698953703321Guidance for industry3434577UNINA