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GUIDANCE DOCUMENT

Regulatory Classification of Pharmaceutical Co-Crystals February 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0800
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification.

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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:

Dockets Management
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-2011-D-0800.

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