• Regulatory NewsRegulatory News

    Alcon’s CyPass Market Withdrawal Escalates to FDA Class I Recall

    A US Food and Drug Administration (FDA) safety communication was escalated to a Class I recall for Alcon’s CyPass micro-stent systems over risk of eye damage in implanted patients.   FDA’s safety communication was issued last month based on a preliminary review of five-year post-surgery data from the COMPASS-XT study conducted by Alcon, the eye care division of Novartis. A second FDA safety alert involving the CyPass device was issued Wednesday in conjunction w...
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    New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety

    A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms. The study, conducted by researchers at Harvard Medical School, Northeastern University, Boston Children's Hospital and The Ohio State University, and funded by FDA's Center for Drug Evaluation and Research, looks specifica...
  • 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 ...
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    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 FDA first introduced the draft guidance after ...
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    Reps Question Gottlieb on Bayer's Follow-Up Essure Studies

    Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) on Monday sent a letter to FDA Commissioner Scott Gottlieb regarding concerns related to Bayer's postmarket study for its permanent birth control device Essure. A year and a half after Bayer's postmarket study was initiated, "It is unclear whether Bayer acted with urgency to enroll patients, or if the study results will be delayed. The FDA cannot continue to allow Bayer to drag its feet on...
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    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...
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    Expedited Approval Pathways Associated With Increased Safety-Related Label Changes, Study Finds

    The US Food and Drug Administration (FDA) is increasingly granting faster reviews via expedited regulatory pathways, but a new article published in the British Medical Journal found a higher association with these expedited pathways and the likelihood of safety-related labeling changes than with non-expedited pathways. In their analysis of 15 years of data, authors Sana Mostaghim, Joshua Gagne and Aaron Kesselheim of the Program on Regulation, Therapeutics, And Law...
  • 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 ...
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    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'...
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    ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

    The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection. ICH says the goal of the guideline, referred to as ICH E19, will be to provide "harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemen...
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    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...
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    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 ...