federal_register: 2018-03133

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2018-03133 Regulatory Classification of Pharmaceutical Co-Crystals; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals." This guidance provides applicants planning to submit new drug applications and abbreviated new drug applications with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. It 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 This guidance finalizes the draft guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals" published in August 2016. 2018-02-15 2018 2 https://www.federalregister.gov/documents/2018/02/15/2018-03133/regulatory-classification-of-pharmaceutical-co-crystals-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2018-02-15/pdf/2018-03133.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 guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals." This guidance provides applicants planning to submit new drug applications...  

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