CSSP - Resources

Food & Drug Administration
  • IND Applications & Guidelines - Guidance Materials provided by the FDA on an IND Application.  Within the bullets are specific documents which may help in developing the application materials.
    • Information about the Investiational New Drug Application (IND)
    • Guidance for the development of an IND
    • Suggestions regarding content.
  • IDE Applications & Guidelines - Guidance Materials provided by the FDA on an IDE Application.  Within the bullets are specific documents which may help in developing the application materials.
International Conference on Harmonization
  • Efficacy Guidelines E1-18
    • Includes guidance regarding study design, conduct, safety and reporting of clinical trials.
    • Covers novel types of medicines derived from biotechnological processes.
    • Use of pharmacogenetics/genomics techniques to produce better targeted medicines.
  • Quality Guidelines Q1-Q12
    • Include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing.
    • Flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
  • Safety Guidelines S1-S11
    • Includes guidance to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity.
    • Non-clinical testing strategy for assessing the QT interval prolongation liability.
  • Multidisciplinary Guidelines M1-M10
    • ICH medical terminology (MedDRA).
    • Common Technical Document (CTD).
    • Development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
National Institutes of Health Good Clinical Practice Guidance Documents