FDA Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds

https://www.gmp-navigator.com/files/guidemgr/clinhld1000.pdf

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/