federal_register: 2016-31627
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-31627 | Botanical Drug Development; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Botanical Drug Development." This guidance describes FDA's current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations for submitting investigational new drug applications (INDs) to support future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This guidance replaces the guidance for industry entitled "Botanical Drug Products" issued in June 2004 and finalizes the August 2015 draft guidance entitled "Botanical Drug Development." | 2016-12-29 | 2016 | 12 | https://www.federalregister.gov/documents/2016/12/29/2016-31627/botanical-drug-development-guidance-for-industry-availability | https://www.govinfo.gov/content/pkg/FR-2016-12-29/pdf/2016-31627.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 "Botanical Drug Development." This guidance describes FDA's current thinking on appropriate development plans for botanical drugs to be... |