This is one in a series of guidances that provide recommendations for applicants preparing the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission to the U.S. Food and Drug Administration (FDA). This guidance provides answers to questions that have arisen since the finalization of the harmonized CTD guidance documents in November 2000. This guidance specifically addresses questions related to safety. Other question and answer (Q &A) guidances are under development to address general questions as well as questions related to quality and efficacy. The questions and answers provided here reflect the consensus of the ICH parties.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.