federal_register: 2016-19876
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-19876 | Disqualification of a Clinical Investigator | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA. | 2016-08-24 | 2016 | 8 | https://www.federalregister.gov/documents/2016/08/24/2016-19876/disqualification-of-a-clinical-investigator | https://www.govinfo.gov/content/pkg/FR-2016-08-24/pdf/2016-19876.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies.... |