federal_register: 2016-19596

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2016-19596 Regulatory Classification of Pharmaceutical Co-Crystals; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals." 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. This draft guidance revises the guidance for industry entitled "Regulatory Classification of Pharmaceutical Co- Crystals" issued in April 2013. 2016-08-17 2016 8 https://www.federalregister.gov/documents/2016/08/17/2016-19596/regulatory-classification-of-pharmaceutical-co-crystals-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/2016-19596.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals." This guidance provides applicants planning to submit new drug...  

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