The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Regulatory Classification of Pharmaceutical Co-Crystals



This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research’s current thinking on the appropriate classification of co-crystal solid-state forms.

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GMP Conferences by Topics

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