• NIH Initiative Hopes to Improve How Preclinical Testing is Reported

    • 11 October 2012
    The National Institutes of Health (NIH) has announced a set of consensus recommendations it says will improve the way preclinical animal studies are designed and conducted, ultimately making them easier to reproduce and understand. The problem, explains NIH, is the gap between conducting animal studies and being able to study the effect of a drug in human trials. "Positive results from animal studies are sometimes difficult to translate into successful clinical trials,...
  • Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

    Two new reports released by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) call for additional oversight over the dietary supplement industry, with government investigators chiding the industry for routinely flouting federal requirements and being difficult to track . That supplement companies routinely run afoul of US Food and Drug Administration (FDA) regulation should be of no surprise to its regulators. Its officials, ...
  • FDA Wants Post-Approval Studies to Address Broader Public Health Needs

    The US Food and Drug Administration (FDA) is preparing a workshop to focus on the design and appraisal of studies conducted after the approval of a product to obtain further evidence of its safety or effectiveness. The studies, otherwise known as post-approval studies (PAS), are often used when there are outstanding questions regarding a product. Many products that receive accelerated approval from US regulators, for instance, must conduct PAS because their initial app...
  • Temple: FDA in Process of Writing Guidance on Boosting Clinical Effectiveness

    The US Food and Drug Administration's Deputy Director for Clinical Science, Bob Temple, often referred to as the agency's " dean of drug development ," has announced the development of a new guidance on finding study populations in which a drug can be properly evaluated. Writing on the Center for Drug Evaluation and Research's (CDER) website on 21 June, Temple described "enrichment design studies"-attempts to boost the clarity of a clinical trial's data by selecting a pa...
  • EMA Proposes Changes to Existing Clinical Trial Guideline on Multiplicity Issues

    The European Medicines Agency (EMA) is calling for a new guideline on multiplicity issues in clinical trials in a new concept paper released on 30 May. EMA first released a paper on multiplicity issues , which are the array of different variables and factors acting upon and within a study, in 2002. "Since then," writes EMA," it has been proven to be useful for both industry and regulators when planning and assessing confirmatory clinical trials." Further advances in me...
  • EMA Releases New Reflection Paper for Labs Performing Clinical Trial Sample Analysis

    The European Medicines Agency (EMA) announced it has released a new reflection paper to guidance laboratories that evaluate clinical trial samples, which it hopes will establish informal guidelines for laboratories. The paper, Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples , will help sponsors to "develop and maintain quality systems which will comply with relevant European Union Directives, national regulations and...
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    ClinicalTrials.gov: Requirements and Implementation Strategies

    The Food and Drug Administration Amendments Act of 2007 ( FDAAA ) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called ClinicalTrials.gov . This law is intended to facilitate enrollment in clinical trials, allow for tracking of the progress of such trials and address problems with the lack of timely dissemination of research fi...
  • 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...
  • 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...