NIH NCATS Preclinical Research Toolbox was developed by NCATS and other NIH Institutes and Centers to help scientists conduct preclinical research
An overview of the drug development process from FDA
An overview of biologics development from the NHLBI Small Biz Hangout
DDTs are methods, materials, or measures (such as animal models, biomarkers, clinical outcome assessments, etc.) that can potentially facilitate drug development. More information and resources on FDA established qualification programs to support DDT development can be found on the link below
Development and approval process review by FDA Center for Biologics Evaluation and Research (CBER)