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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This is one in a series of guidance documents that provide recommendations for applicants preparing a 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 document is intended to describe how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD. This guidance document is intended to be used together with the CTD guidances, described below, and when finalized, it will supercede Guidelines on Formatting, Assembling, and Submitting of New Drug and Antibiotic Applications (February 1987) and the guidance for industry, Organization of an ANDA (February 1998).
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-2001-D-0061.