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  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on PRO Assessment Tool for COPD Trials

    The US Food and Drug Administration (FDA) on Monday finalized guidance to help sponsors developing drugs to treat chronic obstructive pulmonary disease (COPD) to use the St. George’s Respiratory Questionnaire (SGRQ), a patient-reported outcome measure (PRO) assessment tool, in clinical trials. The 8-page guidance, which was revised in draft form in May 2016, notes that sponsors can can use the SGRQ as a PRO assessment of efficacy in submissions to investigational new ...
  • Regulatory NewsRegulatory News

    FDA Offers New Guidance on Qualified Biomarker for COPD Trials

    The US Food and Drug Administration (FDA) on Wednesday issued guidance providing a qualified context of use (COU) for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality. This guidance describes the experimental conditions and constraints for which this biomarker is qualified through the CDER Biomarker Qualification Program, and ca...
  • Regulatory NewsRegulatory News

    FDA Revises Draft Guidance on COPD Drug Development

    The US Food and Drug Administration (FDA) on Thursday released a revised version of its draft guidance intended to help pharmaceutical companies develop products to treat the lung disease known as chronic obstructive pulmonary disease (COPD). Specifically, FDA says the guidance is meant to assist sponsors in determining the efficacy of new drugs to treat the disease in Phase III clinical trials, and includes new information on using health-related quality-of-life instrum...
  • Regulatory NewsRegulatory News

    FDA Ban on CFCs in Asthma Inhalers Raised Costs for Patients, New Study Finds

    An environmental law which required the US Food and Drug Administration (FDA) to revoke the approval of products containing chlorofluorocarbons (CFCs) significantly raised the out-of-pocket expenses borne by patients with asthma, a new study published in the medical journal JAMA Internal Medicine . Background In 1987, the US signed an environmental agreement known as the  Montreal Protocol , an international agreement meant to preserve the ozone layer by phasing out ...
  • Lung Disease Drug Testing Complete Global Approval Sought

    • 27 August 2012
    The final stage of testing for a lung disease drug is finished, and GlaxoSmithKline (GSK) said it will seek global market approval, according to a Reuters report. GSK said the drug, LAMA/LABA, showed positive results in patients with chronic obstructive pulmonary disease (COPD). The company plans to present the full results from four late-stage trials at future scientific meetings. Reuters reports GSK wants to develop a successor to Advair, a lung drug that was reported...
  • COPD Guideline Released by EMA

    The European Medicines Agency (EMA) has released a new guideline on clinical trials conducted to assess chronic obstructive pulmonary disease (COPD) products, updating an existing guideline regulators said had grown outdated. Released 8 August, Guideline on clinical investigation of medical products in the treatment of chronic obstructive pulmonary disease is scheduled to come into effect on 1 September 2012 after more than two years in development. EMA officials sai...