federal_register: 2017-28139
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-28139 | Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled "Best Practices for Communication Between IND Sponsors and FDA During Drug Development." Timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development facilitate earlier availability of safe and effective drugs to the American public. This guidance describes FDA's philosophy regarding timely interactive communication with IND sponsors as a core activity; describes the scope of appropriate interactions between FDA review teams and IND sponsors; outlines the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development programs; describes the general expectations for the timing of FDA responses to IND sponsor inquiries; describes best practices and communication methods to facilitate interactions between FDA review teams and IND sponsors during drug development; and includes expectations on appropriate methods and frequency of such communications. This guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies, or other stakeholders not pursuing a development program under an IND. This guidance finalizes the draft guidance issued on December 9, 2015. | 2017-12-29 | 2017 | 12 | https://www.federalregister.gov/documents/2017/12/29/2017-28139/best-practices-for-communication-between-investigational-new-drug-application-sponsors-and-the-food | https://www.govinfo.gov/content/pkg/FR-2017-12-29/pdf/2017-28139.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 and review staff entitled "Best Practices for Communication Between IND Sponsors and FDA During Drug Development." Timely, transparent, and... |