The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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


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

Document Type:
Guidance for Industry
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.

Go back

GMP Conferences by Topics