Tag Archives: IRB

Drug Regulators, FDA, Publish Information Sheet on Clinical Investigators, Administrative Actions and Disqualifications

Posted on June 6, 2010 by admin| Leave a comment

Drug Regulators, FDA, Publish Information Sheet on Clinical Investigators, Administrative Actions and Disqualifications

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This Guidance document is intended to inform institutional review boards (IRBs), clinical investigators, and sponsors about the administrative action of disqualifying a clinical investigator from participating in studies involving investigational new drugs (including biologics) or devices. FDA may disqualify a clinical investigator from receiving investigational drugs (including biologics) and devices if FDA determines that the investigator has repeatedly or deliberately violated the agency’s regulations, or has repeatedly or deliberately submitted false information to the sponsor or FDA in any required report.

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Drug Regulators, FDA, Publishes Guidance for IRBs, Clinical Investigators and Sponsors

Posted on January 23, 2010 by admin| Leave a comment

Drug Regulators, FDA, Publishes Guidance for IRBs, Clinical Investigators and Sponsors.

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This draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review. When finalized, this document will supersede the Information Sheet, Continuing Review After Study Approval (September 1998, Office of Health Affairs, Food and Drug Administration).

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FDA introduces new Rules of IRB Registration

Posted on July 23, 2009 by admin| Leave a comment

Drug Regulators, FDA, Introduce New IRB registration Rules

Clinical Trials Regulations have been changed following on from the Coast scandal reported in this site (article). I have just received this update from the ICR

The FDA IRB Registration Rule is effective Tuesday, July 14, 2009. All IRBs reviewing FDA-regulated research must register between July 14 and September 14, 2009. IRBs that review FDA-regulated studies and that are not already in the OHRP IRB registration system must submit an initial registration. If your IRB is already registered in the OHRP system, the registration information must be updated to include all of the information required by the FDA IRB Registration Rule. Please see the guidance referenced below for more information.

This registration will be accomplished through a modified version of the database used by the Office for Human Research Protections (OHRP).Please note: the database for electronic submission of IRB registrations will not be available until July 14, 2009.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

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FDA go Mystery Shopping

Posted on April 15, 2009 by admin| 1 Comment

Institutional Review Boards are charged with monitoring clinical trials that go through the institution to ensure patients safety and to ensure the principles for good clinical research are maintained. The FDA has decide to monitor the quality of the decisions being made by some IRB’s in commercial research institutes, in what appears to be a break from the normal methods of Audit, where they review past decisions, in the case of Coast, a for profit Independent review board, the FDA submitted a bogus clinical trial protocol, for a fictitious product and fictitious company, when the board approved the study the FDA sprang its trap. Now Coast are facing some very difficult questions, shedding staff and shedding business.

Mystery shopper is a different path but this author asks where will they take it next, fake safety reports, fake adverse event reports, its the natural evolution of the Audit.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical
or biotechnology) and regulatory consultant, we work with our clients
to define a drug development target, define a drug development
strategy, define a regulatory strategy or define a commercial strategy.
Our clients are generally raising funds or looking to license out their
technology and we help them achieve it. If you want to know more don’t
hesitate to get in touch.

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