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GUIDANCE DOCUMENT

Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001 September 2001

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001

Issued by:
Guidance Issuing Office
Center 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).


Submit Comments

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.