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  • Regulatory NewsRegulatory News

    FDA Alerts on Increased Risks Linked to Pfizer’s Xeljanz

    The US Food and Drug Administration (FDA) alerted the public late Monday of a post-marketing safety clinical trial for Xeljanz (tofacitinib) that found an increased risk of lung blood clots and death in patients with rheumatoid arthritis (RA) who were taking a dose of 10 mg twice daily. The drug safety communication noted the increased risk was observed in the post-marketing trial set as a requirement on Pfizer following the first approval  of Xeljanz in 2012. It comes...
  • Regulatory NewsRegulatory News

    Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

    The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies. The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications ...
  • Regulatory NewsRegulatory News

    Drugged Driving: FDA Finalizes Study Guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on how drugmakers should study the effects of their drugs on driving ability. The guidance is largely in line with the draft version issued in 2015, and continues to recommend that drugmakers follow the "tiered assessment" approach detailed in a 2011 report from the National Highway Traffic Safety Administration's Office of Behavioral Safety Research. FDA first introduced the draft guidance after ...
  • Regulatory NewsRegulatory News

    Rare Diseases: FDA Awards Grants for 21 Clinical, Natural History Studies

    The US Food and Drug Administration (FDA) on Friday awarded $32 million in research grants to fund 15 clinical studies and six natural history studies for rare diseases. The grants are being funded through FDA's orphan products grants program , with $22 million going to the clinical studies and $9.8 million in combined funding from FDA and the National Center for Advancing Translational Sciences' (NCATS) Therapeutics for Rare and Neglected Diseases program going to fund...
  • Regulatory NewsRegulatory News

    FDA Disputes Article Highlighting Lackluster Oversight of Postmarketing Studies

    A paper appearing in the New England Journal of Medicine on Thursday argues that the US Food and Drug Administration (FDA) is not doing enough to ensure drugmakers complete postmarketing studies required by the agency at the time their drugs are approved. In 2007, FDA gained the authority to establish postmarketing requirements for new drugs and biologics under the Food and Drug Administration Amendments Act (FDAAA). The act also gave FDA the authority to warn or fin...
  • Feature ArticlesFeature Articles

    Bioequivalence Studies of Solid Oral Dosage Forms Overview

    The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US. Introduction 'Generic' drugs offer a significant cost saving and are ...
  • Regulatory NewsRegulatory News

    Former CDC Director: Medicine Should Look Beyond Randomized Controlled Trials

    In an article in the New England Journal of Medicine on Thursday, former director of the US Centers for Disease Control and Prevention Thomas Frieden calls for greater use of alternative data sources, other than randomized controlled trials (RCTs), for health care decision making. "For much, and perhaps most, of modern medical practice, RCT-based data are lacking and no RCT is being planned or is likely to be completed to provide evidence for action. This 'dark matter'...
  • Regulatory NewsRegulatory News

    EMA Updates Guidance on Three Post-Authorisation Activities

    The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations. "The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes," EMA writes. Specifically, the updates include a new pre-submission c...
  • Regulatory NewsRegulatory News

    Fears Over Device Surveillance Amid Talk of Deregulation

    A team of researchers say that better postmarketing data for medical devices could identify safety issues sooner, but they fear that current political headwinds could derail planned device safety efforts. In a viewpoint published in JAMA on Thursday, Joshua Sharfstein of Johns Hopkins Bloomberg School of Public Health, and Rita Redberg and Alison Jacoby of the University of California, San Francisco Medical Center, point to the recent debate over power morcellators as ...
  • Regulatory NewsRegulatory News

    FDA Offers Biomarker Qualification Case Studies

    As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers. One follows a researcher who discovers a promising biomarker of drug-induced kidney injury in rats and explores how he partnered with rese...
  • Regulatory NewsRegulatory News

    Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds

    Among 222 novel therapeutics approved by the US Food and Drug Administration (FDA) from 2001 through 2010, 32% were affected by a postmarket safety event, according to a study published in JAMA on Tuesday. Biologics, psychiatric therapeutics and those receiving accelerated approval and near–regulatory deadline approval were statistically significantly associated with higher rates of events, the study found. Of the 222 new drugs and biologics assessed, the study f...
  • Regulatory NewsRegulatory News

    FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds

    For drugs approved by the US Food and Drug Administration (FDA) based on limited evidence, a recent study published in the British Medical Journal found “noticeable variability” in the degree to which novel drugs were studied in the postmarket period. The authors, including Yale University professors Harlan Krumholz and Joe Ross, urged FDA to take a cautious approach in increasing its reliance on surrogate markers, smaller and shorter trials, and evidence derived ...