FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices.
Physicians and other qualified experts (“clinical investigators”) who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, for research involving human subjects, to help protect the rights, safety, and welfare of those subjects.
In certain situations in which FDA alleges a clinical investigator has violated applicable regulations, FDA may initiate a clinical investigator disqualification proceeding.
Others titles
- FDA Clinical Investigators Disqualification
- FDA Administrative Clinical Investigators Disqualification
- FDA Administrative Clinical Investigators Disqualification Proceedings
Keywords
- Clinical Investigators
- FDA Disqualification
- FDA Warning Letters
Clinical Investigators Disqualification Proceedings
$179 / year
The Clinical Investigators Disqualification Proceedings dataset lists clinical investigators who are or have been subject to an administrative clinical investigator disqualification action and indicates the current status of that action.
Complexity
| Date Created | 2013 |
|---|---|
| Last Modified | 2020-08-13 |
| Version | 2020-08-13 |
| Update Frequency | Irregular |
| Temporal Coverage | N/A |
| Spatial Coverage | United States |
| Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
| Source License URL | |
| Source License Requirements | N/A |
| Source Citation | N/A |
| Keywords | Clinical Investigators, FDA Disqualification, FDA Warning Letters |
| Other Titles | FDA Clinical Investigators Disqualification, FDA Administrative Clinical Investigators Disqualification, FDA Administrative Clinical Investigators Disqualification Proceedings |
| Name | Description | Type | Constraints |
|---|---|---|---|
| Name | Clinical investigator name | string | required : 1 |
| Center | FDA center | string | required : 1 |
| City | Clinical investigator city | string | required : 1 |
| State_Abbreviation | Clinical investigator state | string | - |
| Status | Current clinical investigator disqualification proceedings status | string | required : 1 |
| Date_Of_Status | Current status date | date | - |
| Date_NIDPOE_Issued | Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) date | date | - |
| Date_NOOH_Issued | Notice of Opportunity for Hearing (NOOH) date | date | - |
| Date_Of_Presiding_Officer_Report | Presiding officer date | date | - |
| Date_Of_Commissioners_Decision | Commissioner's decision date | date | - |
| Name | Center | City | State Abbreviation | Status | Date Of Status | Date NIDPOE Issued | Date NOOH Issued | Date Of Presiding Officer Report | Date Of Commissioners Decision |
| Robin, Bennett, MD | CDER | Silver Spring | MD | Disqualified | 1964-06-19 | ||||
| Roberts, Kathleen E., MD | CDER | San Francisco | CA | Disqualified | 1964-11-24 | ||||
| Cass, Leo, MD | CDER | Cambridge | MA | Disqualified | 1965-12-15 | ||||
| Copelan, Herbert W., MD | CDER | Philadelphia | PA | Reinstated | 1966-08-19 | ||||
| Kligman, Albert M., MD | CDER | Conshohocken | PA | Reinstated | 1966-08-19 | ||||
| Abruzzi, Jr., William A., MD | CDER | Wappingers Falls | NY | Disqualified | 1966-08-31 | ||||
| Lowe, Leo, MD | CDER | New York | NY | Disqualified | 1966-10-18 | ||||
| Splitter, Samuel, MD | CDER | Hampstead | NY | Disqualified | 1968-07-29 | ||||
| McHardy, Gordon, MD | CDER | NO DATA | Reinstated | 1969-01-27 | |||||
| Bender, Sheldon R., MD | CDER | Philadelphia | PA | Disqualified | 1969-02-17 |
Related Data Packages
- Approved Risk Evaluation and Mitigation Strategies Materials Data
- Approved Risk Evaluation and Mitigation Strategies Products Data
- Clinical Investigator Inspection List
- Clinical Investigators Disqualification Proceedings
- Drugs Application Number and Sponsor
- Drugs Application Submission Property Type
- Drugs Data File Document Addresses
- Drugs Database Marketing Status
- Drugs Database Products Included
- Drugs Database Submissions Included
- Drugs Therapeutic Equivalence Code
- FDA Drug Discontinuation
- FDA Drug Master Files Directory
- FDA Drug Shortages
- FDA Inspections Database
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