PharmStatus

Steps involved in a new drug development process from pre-clinical research to NDA by the FDA

IND (FDA)

ICH Guidelines

IND (wimipedia)

NDA example

FDA forms

IND outline

Clinical Trial Protocol Parts: Synopsis, Investigational plan, Efficacy evaluation, Safety evaluation

Good Clinical Practices

Overview BLA (Biologic License Application)

BLA Examples

Stucture and content of clinical trial protocols

Develop and Manage a Case Report from NCI

GCP - Guidance for Sponsors, Clinical Investigators, and IRBs- Data Retention when Subjects Withdraw from Clinical Trials