Bioresearch Monitoring Information System File (BMIS)
BMIS contains information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs. The information has been abstracted from FDA Forms 1571 and 1572 and other pertinent documents contained in IND submissions (e.g., C.V.s, cover letters, investigator lists, etc.). Please note that this file contains a separate entry for each time an investigator, CRO or IRB is identified in a new submission. For example, if an investigator is named in 10 INDs, his/her name will appear 10 times in this file.
Investigational Human Drugs Clinical Investigator Inspection List
The Clinical Inspection List contains the names, addresses and other information obtained during FDA inspections of clinical investigators who have performed studies with human investigational drugs. The list contains information on investigators inspected since July 1977 whose files have been closed with a final classification.
Warning Letters
A Warning Letter is an informal advisory to a firm communicating the Agency's position on a matter but does not commit FDA to taking enforcement action. The Agency's policy is that a Warning Letter should be issued for violations which are of regulatory significance in that failure to adequately and promptly take corrections may be expected to result in enforcement action should the violation(s) continue.
Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letters
These letters inform 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 FDA'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.
Notice of Opportunity for Hearing (NOOH)
Provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action (such as disqualification), before a presiding officer designated by the Commissioner.
Adequate Assurances List for Clinical Investigators
Contains the names of all clinical investigators who have provided FDA with adequate assurances of their future compliance with requirements applicable to the use of investigational drugs and biologics.
Restricted List for Clinical Investigators
Contains the names of all clinical investigators who have agreed to certain restrictions with respect to their conduct of clinical investigations.
Disqualified/Totally Restricted List for Clinical Investigators
Contains the names of all clinical investigators who have been disqualified or "totally restricted". FDA may disqualify a clinical investigator if he/she has repeatedly or deliberately failed to comply with all applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor.
Application Integrity Policy (AIP)
Describes the Agency's approach regarding the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability. You can obtain information about the enforcement of this policy through this link