Tag Archives: CDISC

  • Drug Development, Approval Process and Electronic Submissions (CDISC)

    Posted on August 27, 2012 by in SAS, SAS in clinical

    Development & Approval Process (Drugs) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm Guidance Documents for Drug Applications http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm090361.htm Laws, Regulations, Policies and Procedures for Drug Applications http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm090410.htm How Drugs are Developed and Approved http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm Conducting Clinical Trials http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/default.htm Forms & Submission Requirements http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/default.htm Electronic Regulatory Review http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085358.htm Electronic Regulatory Submissions http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085324.htm Electronic Regulatory Submissions and Review Helpful Links http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm085361.htm Supporting CDISC […]