News from the World of Clinical Research

Recent News

    Changes to freelance tax status

    By ICR Secretariat / 4/4/2017 12:56:26 PM

    In the Autumn Statement 2016, the chancellor confirmed that, in the public sector only, IR35 status will be determined by the client, not the contractor.

    If a client decides IR35 does apply, the contr…

    FDA reveals recommendations for generics and biosimilars

    By ICR Secretariat / 3/15/2017 1:19:59 PM

    The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics.

     

    Mixed response to new UK budget

    By ICR Secretariat / 3/15/2017 1:12:34 PM

    The spring budget from Philip Hammond has been described as ' a step in completely the wrong direction' by Dr Chris Moulton, but it came with promises to develop new STEM talent, and keep the UK at th…


    HRA to speak on "Trials for the Future"

    By Alison Messom / 3/13/2017 7:46:21 PM

    ICR are pleased to announce that HRA will be presenting at our Forum to Celebrate International Clinical Trials Day - 17th May.

     

    For more information and to book

    EMA Outlines GCP Inspection Plan

    By ICR Secretariat / 3/7/2017 1:42:31 PM

    The EMA has outlined their guidance for GCP inspections for the coming 2017 year. They include working with the FDA, defining a well sampled scope for inspections, and defining in advance the number o…

    EMA reviews Actelion PAH drug after patient deaths

    By ICR Secretariat / 2/21/2017 1:33:06 PM

    The European Medicines Agency has launched a safety review of Actelion Pharma's pulmonary arterial hypertension medicine Uptravi (selexipag) to investigate the deaths of 5 patients taking the drug in …


    HRA publishes new proportionate consent guidence

    By ICR Secretariat / 2/21/2017 12:13:34 PM

    “Our guidance encourages researchers to take a proportionate approach to seeking consent, so that they can avoid presenting detailed and lengthy information which can deter and confuse potential parti…

    5 Things to Watch on the Drug Approval process

    By ICR Secretariat / 2/21/2017 12:05:36 PM

    Dr. Robert Califf, who stepped down last month, shares his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency.