Enforcement Actions

 
This page provides links, for example, to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel:

Statements

Enforcement Policy Statement

Revisions

Revisions, Drafts, and Updates to ORA compliance references

 

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.
• Disqualified/Restricted/Assurance List for Clinical Investigators
  Restricted from receiving investigational drugs, biologics, or devices if FDA determines that the investigator has repeatedly or deliberately failed to comply with regulatory requirements for studies or has submitted false information to the study's sponsor.
• 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.
• FDA NIDPOE Letters
  A Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter informs the recipient clinical investigator that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to the Food and Drug Administration's regulations. Generally, FDA issues a NIDPOE letter when it believes it has evidence that the clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor.
• 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.