• Regulatory NewsRegulatory News

    FDA says IRB review still needed for IVD studies involving human specimens

    The US Food and Drug Administration (FDA) reiterates that clinical studies of in vitro diagnostic devices (IVDs) using leftover, "deidentified" human specimens still have to be approved by Institutional Review Boards (IRBs).   This pronouncement was made in an 18 October reminder letter to IVD manufacturers by William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality within FDA’s Center for Devices and Radiological Health. ...
  • Regulatory NewsRegulatory News

    India’s CDSCO Releases New Clinical Trial Guidelines

    India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials.  New policies stated in the documents include: Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical; Investigators are limited to working on a maximum of three trials simultan...
  • China Proposes Stem Cell Clinical Trial Rules

    China's Ministry of Health and the State Food and Drug Administration (SFDA) have proposed draft regulations governing stem cell clinical trial management and the quality control of stem cell preparations and pre-clinical research. All proposed clinical trials on stem cells would be subject to prior review by ethics committees, and sponsors would be required to submit informed consent forms, safety evaluation and research protocols as well as information concerning th...
  • FDA Draft Guidance Seeks Clarity on IRBs' Clinical Research Oversight Responsibilities

    A new draft guidance published by the US Food and Drug Administration (FDA) aims to clarify the responsibilities of institutional review boards (IRBs) in the oversight of investigators, research sites and investigational authority of sponsors. The draft guidance, IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed , aims to clarify the roles of IRBs, which are charged ...