1. Guidelines on Good Pharmacovigilance Practices (GVP),2021
2. European Commission Health and Food Safety Directorate-General Health Systems, Medical Products and Innovation Medicines: Policy, Authorisation and Monitoringhttps://ec.europa.eu/health/sites/health/files/files/committee/stamp/stamp6_off_label_use_background.pdf
3. Food and Drug Administration Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND,2013