FDA Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Holds
Title:
FDA Guidance for Industry
Submitting and Reviewing Complete
Responses to Clinical Holds
Origin/Publisher:
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/
Document Type:
Guidance for Industry
Content:
This guidance is intended to describe how applicants should submit responses to clinical holds so that they may be identified as complete responses and the Agency can track the time to response.