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  • MHRA Announces 'Procedural Changes' for Submission of Labels, Patient Leaflets

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced last week (29 March) it would be making "procedural changes" to the process by which sponsors of marketing authorization applications (MAAs) submit full-color mock-ups of labels and patient leaflets. In its new guidance, Labels & Patient Leaflets in the Initial & Final Submission Documents for New MA and Type 1B or Type II Variation Applications , MHRA notes several changes, including:...
  • FDA Releases Final Guidance on Overseeing Clinical Trials

    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for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval finalizes draft guidance by the same name released by FDA in January 2010. The guidance aims to provide specific recommendations for Institutional Review Boards, sponsors and clinical investig...
  • Feature ArticlesFeature Articles

    Sunshine Comes to Clinical Trials: Sponsors, CROs, Physicians and Teaching Hospitals Need to Prepare for Federal Financial Disclosure

    A provision of the healthcare reform law has created a new need for clinical trial sponsors and other participants to be open about financial relationships. On 19 December 2011, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule that would require applicable manufacturers, including many clinical trial sponsors, to disclose certain financial relationships with physicians and teaching hospitals. The concept is nothing new, as the rule implement...