• Regulatory NewsRegulatory News

    Cancer Gene Therapies: FDA Officials Highlight Regulatory Approaches

    As gene therapies begin to get a foothold among other cancer treatments, the US Food and Drug Administration (FDA) is taking a more flexible, data-driven approach for the preclinical testing programs of these biologically complex products, according to a new review from five FDA officials in Cancer Gene Therapy . Although FDA has yet to approve a gene therapy to treat cancer, the authors note that about two-thirds of gene therapy clinical trials are for cancer treatment...
  • Regulatory NewsRegulatory News

    FDA Warning Letter Details Serious Violations by another Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released another Warning Letter for an Active Pharmaceutical Ingredient (API) and drug manufacturer in India with a series of severe findings. The most recent letter sent to Gujarat, India-based Pan Drugs, which is already barred from supplying drugs and APIs to the US, follows the identification of more Current Good Manufacturing Practices (CGMP) violations by FDA inspectors, including data integrity issues, as well a...
  • Regulatory NewsRegulatory News

    EMA Issues Guidance on Clarification Meetings

    The European Medicines Agency (EMA) is looking to increase transparency between its committees and pharmaceutical companies under a new guideline that went into effect in February 2015. The guideline, EMA/636600/2014, details procedures regarding clarification meetings in response to questions raised by the agency during the review of a product using the centralized procedure. Clarifying Objections EMA believes increasing transparency between the agency and applicant...
  • Regulatory NewsRegulatory News

    Federal Commission Prepares to Weigh in on Ethics of Testing Ebola Treatments

    President Barack Obama's bioethics commission is preparing to weigh in on whether the US Food and Drug Administration (FDA) should require manufacturers of investigational products intended to either treat or prevent the Ebola virus to run clinical trials with placebo controls. Are Placebos Ethical? The issue of placebo controls has been a contentious one to regulators and ethicists around the globe. At issue: Since Ebola has such a high rate of mortality, should all ...
  • 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...
  • J&J Earnings Drag as Regulatory Problems Accumulate

    Life sciences giant Johnson & Johnson (J&J) managed to increase first quarter profits by 12.5% despite a decrease in revenue of 0.2%, the company said in a statement. But the company's profits were sorely depressed by a series of regulatory issues, including recalls, shortages and legal battles, reports The Associated Press. Among J&J's many issues during Q1: The US Department of Justice rejected a settlement between the company and the US government ove...
  • FDA Releases New Framework for Classifying Postmarket Drug Safety Issues

    The US Food and Drug Administration released new draft guidance on 8 March on classifying significant postmarket drug safety issues . The classification system-a three-tier approach in which postmarket drug safety issues are either classified as standard, priority or emergency-was developed under the Center for Drug Evaluation and Research's (CDER) Safety First Initiative . The classification system is intended to cover postmarketing safety issues such as serious adve...
  • DOJ Files 'Groundbreaking' Consent Decree Against Ranbaxy, Company Agrees to 'Remedy Deviations'

    The US Department of Justice (DOJ) filed a Consent Decree of Permanent Injunction against Ranbaxy, an Indian generic drug manufacturer, with the US District Court of Maryland on 25 January. The action was taken on behalf of the US Food and Drug Administration (FDA), which had found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and a US-based Ranbaxy subsidiary's facility in New York. The consent decree requires Ranbaxy to c...
  • Manufacturing Mix-ups Affect Novartis, Endo Pharmaceuticals

    Swiss pharmaceutical company Novartis Consumer Health Inc. recalled four products yesterday, citing quality concerns that could expose consumers to " foreign tablets, caplets, or capsules ," as well as broken and chipped pills. The product recall affects four popular Novartis-made drugs: Excedrin, NoDoz, Bufferin and GasX. The US Food and Drug Administration's (FDA) statement noted that consumers could be exposed to dangerous doses, unintended ingredients, allergic reac...