• Regulatory NewsRegulatory News

    European Commission Revises Q&A on Safety Features for Medicinal Products

    The European Commission on Monday released a revised question and answer document regarding the implementation of the rules on the safety features for medicinal products for human use. Revisions in the document are related to two questions and answers, including one on if a pack bearing safety features is lawfully opened by, for instance, parallel traders or manufacturers replacing the leaflet, can the pack be resealed? The answer notes that in certain circumstances it ...
  • Regulatory NewsRegulatory News

    Medical Device Safety Action Plan: FDA Sets Measure of Success Amid Funding Issues

    The US Food and Drug Administration (FDA) updated its medical device safety action plan on Tuesday with “an important and ambitious new goal” and explained the path forward for its planned nationwide device surveillance system.   The new goal to propel the safety action plan— released in April—is centered around ensuring that the agency is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” FDA...
  • Regulatory NewsRegulatory News

    FDA Warns Against Using Implanted Pumps With Unapproved Drugs

    The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid with drugs they were not approved for use with.   Using drugs that have not been approved for compatibility with the pumps could lead to dosing errors, pump failure, opioid withdrawal, infection, fever, vomiting, muscle spasms, cognitive changes and cardiac or respiratory distress, FDA says.   “The...
  • Regulatory NewsRegulatory News

    Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

    Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the US Food and Drug Administration (FDA) said Thursday.   The agency summarized the new information from both medical device manufacturers and provided updated recommendations in two letters to health care providers. Medtronic issued three advisory letters between June and August t...
  • Regulatory NewsRegulatory News

    Pfizer and Mylan Report EpiPen Label Defect Could Delay, Prevent Emergency Use

    The US Food and Drug Administration (FDA) recently issued a safety alert to inform that EpiPen manufacturer, Pfizer, has become aware that the label sticker on certain auto-injectors “may have been improperly applied, causing resistance when removing it from the carrier tube.”   The safety alert affects Mylan’s EpiPen 0.3 mg and EpiPen Jr 0.15 mg containing labeled expiries on both the devices and cartons between June 2018 and February 2020 and between October 2018 a...
  • 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...
  • Regulatory NewsRegulatory News

    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

    Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

    This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and dru...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FSMA and its Impact on Dietary Supplement Companies

    This article discusses FSMA-related regulations and stresses the impact the regulations will have on the dietary supplement industry. Introduction Since the Food Safety Modernization Act (FSMA) was signed into law in January of 2011, regulatory professionals in the food and dietary supplement areas have been barraged. 1 Seldom has one act had as many touch points in food regulation. For dietary supplement companies, FSMA's broad scope and hefty volume have made it a ...
  • Regulatory NewsRegulatory News

    The US Regulatory Environment for Probiotics in Food

    This article discusses the US Food and Drug Administration's (FDA's) revised draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, and its potential impact on the regulatory status of probiotic ingredients. It outlines the opportunities for probiotics as medical foods, as well as the potential regulatory challenges associated with this category. The author encourages probiotics manufacturing companies to engage in 'self-regulatory ...
  • Regulatory NewsRegulatory News

    Intractable Epilepsy and the Value of Formulated Ketogenic Diet Products

    This article discusses the benefits of the Ketogenic Diet (KD) and the Modified Atkins Diet (MAD) for adults and children as treatments for intractable epilepsy. It offers a patient-oriented interpretation of regulatory requirements for medical foods as well as study data demonstrating KD efficacy. The article was based on a presentation given at the 2017 RAPS Convergence, during the medical food session on Modification of Diet Alone (MODA) vs. access and convenience mat...