Inspections, Compliance, Enforcement, and Criminal Investigations
Other Compliance Documents
- Application Integrity Policy
Regarding the integrity of data and information in applications submitted for FDA review and approval.
- Bioresearch Monitoring Program
(BIMO) of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO Program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals, as well as, to provide for protection of the rights and welfare of the thousands of human subjects involved in FDA regulated research.
- Clinical Investigator-Disqualification Proceedings
FDA's new Clinical Investigator - Disqualification Proceedings database provides a list of clinical investigators who are or have been subject to an administrative clinical investigator disqualification action and indicates the current status of that action. For each clinical investigator who is listed, links to related FDA regulatory documents (e.g., NIDPOEs, NOOHs, Presiding Officer Reports, Commissioner's Decisions) are provided, when available.
- Electronic Records; Electronic Signatures, 21 CFR Part 11
Background information and updates on the rule that allows the use of electronic records and electronic signatures for any record that is required to be kept and maintained by other FDA regulations.
- FDA Debarment List
Firms or individuals convicted of a felony under Federal law for conduct (by a firm) relating to the development or approval, including the process for development or approval, of any abbreviated drug application; or (an individual convicted) for conduct relating to development or approval of any drug product, or otherwise relating to any drug product under the Federal Food, Drug, and Cosmetic Act.
- Public Health Service (PHS) Administrative Actions Listings
Of certain individuals who have had administrative actions imposed against them. The list is maintained by the PHS Office of Research Integrity (ORI).
- Reading Room (Electronic Freedom of Information Act)
ORA documents frequently requested by the public through the Freedom of Information Act.
Recalls & Alerts