federal_register: 2017-25454
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-25454 | Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop | Notice | The Food and Drug Administration (FDA, the Agency, or we) is announcing the public workshop entitled "Safety Assessment for IND Safety Reporting." Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to "Safety Assessment for Investigational New Drug (IND) Safety Reporting." This public workshop is organized in response to public comments received to Docket No. FDA-2015-D-4562 for the draft guidance "Safety Assessment for IND Safety Reporting" issued in December 2015 requesting a public meeting to discuss the draft guidance and its implications. The public workshop is intended to engage external stakeholders in discussions related to finalizing the draft guidance entitled "Safety Assessment for IND Safety Reporting." | 2017-11-27 | 2017 | 11 | https://www.federalregister.gov/documents/2017/11/27/2017-25454/safety-assessment-for-investigational-new-drug-safety-reporting-public-workshop | https://www.govinfo.gov/content/pkg/FR-2017-11-27/pdf/2017-25454.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, the Agency, or we) is announcing the public workshop entitled "Safety Assessment for IND Safety Reporting." Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by... |