• Regulatory NewsRegulatory News
    TrackersTrackers

    FDA Drug Advertising Study Tracker

    The US Food and Drug Administration (FDA) frequently studies consumer behavior, particularly as it relates to how members of the public (and medical professionals) understand pharmaceutical advertising. Our FDA Drug Advertising Study Tracker keeps tabs on these studies and explains what they're trying to accomplish in plain terms.   Date Topic Study Summary January 2012 Corrective Advertising Study to assess whether and how corrective advertising—used to cor...
  • Regulatory NewsRegulatory News

    EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts

    In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse. Background Regulators use reports based on this literature differently. In most regions...
  • FDA Says it Wants to Make Anticoagulants, Opioids and Diabetes Drugs Safer for Patients

    The US Food and Drug Administration (FDA) wants to fund studies that will help it increase the safety of pharmaceutical and biological products even after they've been approved, it has announced. Background The announcement was made on 21 February 2014 as a technical amendment to an earlier " broad agency announcement "-essentially a wish list of regulatory science initiatives FDA said it planned to spend as much as $50 million on in the coming months. The original a...
  • FDA Guidance Establishes When an IND May Not be Required to Conduct Human Studies

    The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist sponsors in determining whether a research study involving human subjects may be conducted without first filing an investigational new drug (IND) application with US regulators. Background: The FMT Precedent In recent months, FDA has proven to be somewhat amicable to the idea of extending enforcement discretion-that is, expressing that it won't punish an entity-when h...
  • 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,...
  • 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...