• EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

    The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified cells. The scientific guideline addresses the three main areas of drug development: quality considerations within the manufacturing process, non-clinical testing and clinical testing. EMA notes genetically modified cells may either be used as therapies themselves or as part of t...
  • FDA Disputes Study Findings, Goes After Some Clinical Trial Sponsors

    Months after the British Medical Journal ( BMJ ) reported that the US Food and Drug Administration's (FDA) oversight of its clinical trials database was suffering from serious lapses in clinical trial reporting and transparency , US regulators are firing back, charging that the studies' authors "overstated non-compliance with data reporting laws," reports Nature . The studies published in BMJ found some troubling occurrences, including a 78% non-compliance rate wit...
  • FDA: Companies Who Dealt With Cetero Must Repeat or Confirm Some Bioanalytical Studies

    The US Food and Drug Administration (FDA) moved on 23 April to notify pharmaceutical companies who had contracted out bioanlytical studies to contract research organization Cetero, which FDA has accused of conducting falsified studies. The agency conducted inspections of Cetero's Houston, Texas-based facilities twice in 2010, and "identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of...
  • EMA Posts Revised Integrated Guidance on Use of Centralized Procedure

    The European Medicines Agency (EMA) has released a revised integrated guidance document containing advice for user of the centralized procedure. EMA's 18 April revision of the Q&A document represents its 21 st revision, and is a comprehensive resource including information from a wide range of regulations and guidances. "This guidance document addresses a number of questions which marketing authorization holders (MAHs) may have on post-authorization procedures," ex...
  • Russia: New Clinical Trial Regulations In Effect

    New regulations governing the conduct of preclinical studies and clinical trials of drugs for medical use have entered into force in Russia, which require the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) to implement control measures and the analysis of study and trial results.  The regulations also establish appeal procedures for Roszdravnadzor decisions. The changes stem from an order of the  Ministry of Health issue...
  • New Guidance on Studies Involving Geriatric Patients Released by FDA

    The US Food and Drug Administration (FDA) released a final guidance on 21 February that provides insight into how sponsors should conduct clinical trials when their studies are likely to involve elderly patients. FDA's Guidance for Industry - E7 Studies in Support of Special Populations: Geriatrics conforms to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document of the same nam...
  • GHTF Releases Proposed Changes to SG5 Clinical Performance Studies for IVDs

    The Global Harmonization Task Force released a new proposed document for their Study Group 5 (SG5) category called " Clinical Performance Studies for In Vitro Diagnostic Medical Devices ." The document provides guidance for IVD medical devices, including the selection of clinical performance study design and the considerations to be made when undertaking those studies. The document notes that "As IVD medical devices are used on specimens taken from the human body, th...
  • EMA Calls for Guidelines on the Use of Pharmacogenomics in Pharmacovigilance Evaluation

    The European Medicines Agency (EMA) issued a concept paper on 23 January that calls for a new guideline to be issued on the use of pharmacogenomics in the conduct of pharmacovigilance. The concept paper notes that the response most individuals have to drug therapy is highly variable, and a prominent component of this variability is related to genetic variations. This can relate to drug disposition (pharmacokinetics) or drug action (pharmacodynamics). Accurate knowledg...
  • FDA Orders Surgical Mesh Manufacturers to Study Risks

    The US Food and Drug Administration (FDA) issued a safety communication yesterday warning consumers about problems associated with surgical mesh implants and ordering manufacturers of the devices to conduct new studies in light of those safety concerns. The mesh, used to treat pelvic organ prolapse and stress urinary incontinence , has been associated with pain, infections, urinary problems, bleeding and discomfort .  FDA said that it has received more than 1,...
  • BMJ: Lack of Research Transparency Breaks Regulations, Hurts Patients

    A series of studies published this week in the British Medical Journal by groups of researchers from various universities have found serious lapses in clinical trial reporting and transparency . Among the findings: A study led by Andrew Prayle of Nottingham University found that only 22% of trials registered at ClinicalTrials.gov had reported their results in the mandatory one-year post-trial time frame; A study conducted by researchers at the Yale School of M...