FDA: Compliance & Enforcement

Please find here  links to information about clinical investigators who have and/or are participating in clinical trials of pharmaceutical products as well as regulatory correspondence and restrictions resulting from noncompliance observed during bioresearch monitoring (BIMO) inspections.

Regulatory Activities

Clinical Investigator List

The Clinical Investigator Inspection List, maintained by the Center for Biologics and Evaluation Research, contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER. These inspections were conducted as part of the Food and Drug Administration’s Bioresearch Monitoring Program. This list contains information on inspections that were closed after 1989.

Click here to check the details: Clinical Investigator List (PDF – 3.13 MB)

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.

Click here to check the details: Bioresearch Monitoring Information System File (BMIS)

Investigational Human Drugs Clinical Investigator Inspection List

The Clinical Inspection List, maintained by the Center for Drug Evaluation and Research, 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.

Click here to check the details: Investigational Human Drugs Clinical Investigator Inspection List

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.

Click here to check the details: Warning Letters

Source: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplianceEnforcement/default.htm

2 Responses to FDA: Compliance & Enforcement

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