1. European Medicines Agency Pre-Authorisation Evaluation of Medicines for Human Use, Committee For Medicinal Products For Human Use (CHMP) Guideline: Clinical Investigation of Medicinal Products in the Treatment of Parkinson's Disease London
2. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Guidance for Industry: Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators Silver Spring, MD FDA