• Reimbursement Hurdles Focus of EU Consultation on Post-Authorization Studies

    The European Commission has launched a consultation on the "situations" in which post-authorization studies would be imposed, something required by the 2010 legislation that revamped the EU pharmacovigilance system. The Commission's reflection paper notes in the section on "Efficacy Versus Effectiveness" that the criteria used by the European Medicines Agency (EMA) for a marketing approval recommendation have been the subject of some debate in recent years.  The...
  • NIH to Publish Updated List of Priority Therapeutic Areas for Pediatric Research

    • 25 October 2012
    The National Institutes of Health (NIH) is preparing to release a new report detailing the therapeutic needs of pediatric patients under the Best Pharmaceuticals for Children Act (BPCA) , a piece of legislation aimed at promoting the safe prescribing of medicines for children. The 2002 law, similar to the Pediatric Research Equity Act (PREA) , allows FDA to work with sponsors of certain therapeutic products to conduct postmarketing studies involving children in ret...
  • Senate Investigation Claims Medtronic Edited, Influenced Studies

    • 25 October 2012
    A new report released by the Senate Finance Committee slams medical device manufacturer Medtronic for allegedly ghostwriting studies used to support its Infuse Bone Graft system and paying hundreds of millions of dollars to experts who authored company-sponsored studies. The 2,300-page report (PDF, 150 MB) was triggered in part by a 2009 investigation conducted by Med Page Today and the Milwaukee Journal-Sentinel that found the company to have engaged in ghostwri...
  • 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,...
  • FDA Marks Half-Century of Regulation Based on Safety, Efficacy

    A half-century ago today, the US Food and Drug Administration (FDA) experienced perhaps its greatest expansion of regulatory authority since its inception, allowing it to regulate pharmaceutical products based not only on the safety of a product but their efficacy as well. That authority, granted by the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act of 1938, came in the wake of an international regulatory crisis involving Thalidomide, a drug in...
  • 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...
  • ICH Publishes New Guideline on Clinical Study Reports

    The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released a new question and answer document for its E3: Structure and Content of Clinical Study Reports ("The E3 Guideline") guideline. Writing on 21 June 2012, ICH said the document was finalized in mid-June as part of Step 4 of its Q&A Procedure process, indicating the document has reached consensus status and is in the proces...
  • 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...