SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications

https://www.fda.gov/media/88774/download?attachment=&utm_medium=email&utm_source=govdelivery SOPP 8217: Administrative Processing and Review Management Procedures for Investigational New Drug Applications https://www.fda.gov/media/156718/download?attachment=&utm_medium=email&utm_source=govdelivery