|This page provides links, for example, to
documents, lists, policies, programs, and statements relating to Compliance References
used by FDA personnel:
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
- 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
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.
- 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 of FDA Regulated Products
Information regarding guidance to industry on product recalls, model
press releases for product recalls, and links to FDA listings of
recalls: the most recent and critical recalls, and weekly archives
of all recalls from approximately 1990.