federal_register: 2011-31022

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-31022 Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft guidance also provides information about the data that should be submitted to support the appropriate classification of a co-crystal and the regulatory implications of the classification. 2011-12-02 2011 12 https://www.federalregister.gov/documents/2011/12/02/2011-31022/draft-guidance-for-industry-on-regulatory-classification-of-pharmaceutical-co-crystals-availability https://www.govinfo.gov/content/pkg/FR-2011-12-02/pdf/2011-31022.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and...

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