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: M4S: The CTD - Safety Appendices

Origin/Publisher:

Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Document Type:
Guidance
Content:
This document contains tables and figures merely as examples and can be used by applicants but in a format appropriate to the product.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK