• Regulatory NewsRegulatory News

    FDA Revises Policies on Obtaining Informed Consent in Clinical Trials

    A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent. Informed Consent: The Basics As FDA explains in the draft guidance, Informed Consent Information Sheet , when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this...
  • Regulatory NewsRegulatory News

    FDA Finalizes IRB Transfer Guidance With Minimal Changes

    • 22 May 2014
    The US Food and Drug Administration (FDA) has announced the release of a final document intended to instruct sponsors, clinical investigators and institutional review boards (IRB) about how to transfer the oversight of clinical trials to a new IRB. The guidance, Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board , was first released in draft form in June 2012 by FDA and the US Department of Health and Human Servic...
  • FDA Blasts Clinical Investigation in Warning Letter, Saying Deviations Impacted Study Validity, Integrity

    Failure to follow the agreed-upon protocol for a clinical trial for an investigational pain pill product has earned a clinical investigator a Warning Letter from the US Food and Drug Administration (FDA), the agency has announced. Deviating from Protocols The letter to Henry Frazer of Montgomery, AL-based Drug Research and Analysis Corporation said FDA investigators had observed "objectionable conditions" during a Bioresearch Monitoring (BIMO) program checkup on Fraze...
  • Final FDA Guidance on IRBs Illustrates Common Problems Faced in Trial Setup Phase

    The US Food and Drug Administration (FDA) has announced the publication of a new guidance document intended to guide institutional review boards (IRBs), clinical investigators and sponsors of clinical trials on whether clinical sites are compliant with regulations and whether an investigational application must be submitted to FDA. Background Clinical research is at the heart of FDA's regulatory oversight capacity. Good review decisions rely on good clinical data-r...
  • FDA Announces Additional Restrictions on Disqualified Clinical Investigators

    The US Food and Drug Administration (FDA) is announcing changes to its rules governing how clinical investigators are disqualified, vastly expanding the scope of the disqualification. Under existing rules, if FDA determined a clinical investigator has broken rules such that the agency disqualifies them from conducting clinical investigations on one type of test article (e.g. drugs), they may still be allowed to investigate other, non-related products (e.g. medical device...