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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
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 presents the agreed upon common format for the preparation of a well-structured Common Technical Document for applications that will be submitted to regulatory authorities. A common format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will ease the preparation of electronic submissions. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements. In addition, exchange of regulatory information between regulatory authorities will be simplified.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-5139.