federal_register: 2013-09872
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-09872 | Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals." This 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 regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data the applicant should submit to support the appropriate classification of a co-crystal, as well as the regulatory implications of the classification. The recommendations in this guidance apply to materials that the Agency has not previously evaluated and determined to be pharmaceutical co-crystals. The recommendations do not apply to materials that the Agency has previously designated as salts, complexes, or other non-co- crystalline forms. | 2013-04-26 | 2013 | 4 | https://www.federalregister.gov/documents/2013/04/26/2013-09872/guidance-for-industry-on-regulatory-classification-of-pharmaceutical-co-crystals-availability | https://www.govinfo.gov/content/pkg/FR-2013-04-26/pdf/2013-09872.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Regulatory Classification of Pharmaceutical Co-Crystals." This guidance provides applicants of new drug applications (NDAs) and abbreviated new... |