News

Latest News | 9 November 2012

Animal Research Oversight in Need of Reform, Argues Researcher

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Are Institutional Animal Care and Use Committees (IACUCs)—groups used to ensure research conducted on animals meets basic ethical standards—meeting their ethical responsibilities and the original Read More...

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Latest News | 17 October 2012

Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

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The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority Read More...

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Latest News | 15 August 2012

FDA Warning Letter Cites IRB for Data Collection Deficiencies

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A warning letter sent to an institutional review board (IRB) by the US Food and Drug Administration (FDA) accuses the New York-based board of failing to document many of its activities in violation of Read More...

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Latest News | 13 June 2012

Warning Letter Analysis: Institutional Review Boards Cited for Deficiencies

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Two institutional review boards (IRBs) have been the subject of warning letters from the US Food and Drug Administration (FDA) in as many weeks after the agency discovered alleged deficiencies Read More...

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Latest News | 11 June 2012

Federal Agencies Team Up to Issue Draft Guidance on IRB Transfers

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The US Food and Drug Administration (FDA) has released a draft guidance intending to instruct sponsors, clinical investigators (CIs) and Institutional Review Boards (IRBs) on best practices for Read More...

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Latest News | 10 May 2012

FDA: Use of Medical Device in MS Patients 'Unproven,' Risky

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The US Food and Drug Administration (FDA) sent out a warning to health professionals on 10 May warning them of the dangers associated with the use of a balloon angioplasty device to widen narrowed Read More...

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Latest News | 16 April 2012

Texas Approves New Stem Cell Therapies, Setting up Possible FDA Showdown

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The state of Texas approved new—and controversial—rules to allow doctors to use adult stem cells to conduct institutional review board (IRB)-approved procedures on patients, reports The New York Read More...

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Latest News | 27 February 2012

FDA Releases Final Guidance on Overseeing Clinical Trials

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The US Food and Drug Administration (FDA) released new guidance 27 February on clinical trials oversight occurring after clinical investigation approval (CIA).Guidance for IRBs, Clinical Read More...

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Latest News | 9 February 2012

FDA Releases Small Entity Compliance Guide for Informed Consent Elements

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The US Food and Drug Administration (FDA) released a guide to the informed consent process for sponsors, investigators and institutional review boards (IRBs) entitled Questions and Answers on Informed Read More...

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Latest News | 12 January 2012

RAND Study: Inefficient IRBs Add Costs, Delay Regulatory Approval

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A RAND Corporation study of Institutional Review Boards (IRBs) released in the December issue of The Milbank Quarterly titled, Burdens on Research Imposed by Institutional Review Boards: The State of Read More...

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