• RoundupsRoundups

    EU Regulatory Roundup: EMA Set to Restart Activities Despite Brexit Impact on Staff Numbers

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA Set to Restart Activities Despite Brexit Impact on Staff Numbers   The European Medicines Agency (EMA) is preparing to restart activities it paused as part of its move from London to Amsterdam. However, with EMA suffering the highest rate of staff turnover in its history, the work will be spread across a smaller number of employees than in the past.   EMA st...
  • Regulatory NewsRegulatory News

    Internal FDA Emails Reveal How Price, Sanders’s Pressure Played a Role in Competitor’s Approval, Catalyst Claims

    A series of partially redacted internal emails from the US Food and Drug Administration (FDA), released as part of a lawsuit related to competing treatments for the rare disorder Lambert-Eaton Myasthenic Syndrome (LEMS), attempt to show how price and Sen. Bernie Sanders’s (D-VT) pressure played a role in FDA’s approval of a competitor. The case concerns Catalyst Pharmaceuticals, which sued FDA last June in the US District Court for the Southern District of Florida bec...
  • Regulatory NewsRegulatory News

    FTC Sues Two Supplement Companies to Stop Unverified Marketing Claims

    The Federal Trade Commission (FTC) said this week that it has sued two companies that made unsubstantiated claims while marketing their products containing the active ingredient cyplexinol. One of the companies, Excellent Marketing Results, Inc. (EMR) and its president, agreed to settle with the FTC and will be prohibited from making health-related product claims unless they are supported by scientific evidence. The proposed order imposes a $3.6 million judgment against...
  • Regulatory NewsRegulatory News

    FDA Revises Atherectomy 510(K) Guidance in Response to Cook Comments

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance laying out its expectations for 510(k) submissions for peripheral vascular atherectomy devices, which are used to remove plaque in the peripheral vasculature through cutting, shaving, sanding or vaporization.   The 27-page guidance finalizes a draft version released in 2018 and includes recommendations for the descriptive characteristics, labeling, biocompatibility, sterility, nonclinical, anim...
  • Regulatory NewsRegulatory News

    CDER’s Controlled Substances Program Finds New Leader

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) on Wednesday said that its newly established Controlled Substances Program (CSP) will be led by Marta Sokolowska, associate director for controlled substances in the Office of the Center Director.   CSP, which encompasses the Controlled Substances Staff (CSS) and Controlled Substances Initiatives (CSI), will help to coordinate CDER activities and emerging issues around controlled subst...
  • ReconRecon

    Recon: J&J Partners with HHS on Coronavirus Vaccine; Dr. Reddy’s to Acquire Part of Wockhardt’s India Business for $260M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Johnson & Johnson partners with US agency to develop coronavirus vaccine ( Reuters ) ( Press ) Coronavirus-Drug Development Becomes a Top Focus at Gilead ( WSJ ) Coronavirus sparks US concern over medical supplies ( Financial Times ) Seattle Genetics makes case for Padcev plus Keytruda in first-line bladder cancer ( PMLive ) ( Press ) Easing concerns, FibroGe...
  • Feature ArticlesFeature Articles

    The Changing Role of the Regulatory Professional

    This article discusses the widening range of responsibility for regulatory professionals and the increasing importance of their role to an organization’s bottom line. The author covers the value of continuously developing new skills in addition to regulatory and scientific knowledge to more effectively interface with colleagues with a variety of expertise. She highlights the effects of increased regulatory scrutiny, such as through compliance with the European Union’s new ...
  • Regulatory NewsRegulatory News

    Medtronic Recalls Insulin Pumps After More Than 2,000 Injuries, One Death

    The US Food and Drug Administration (FDA) on Wednesday announced that Minnesota-based device manufacturer Medtronic is recalling certain insulin pumps that might not provide the correct insulin dosing. The Class I recall, the most serious type of recall, was first announced by Medtronic last November for 322,005 of its US-distributed MiniMed 600 Series Insulin Pumps (481,875 of the devices were distributed worldwide). The recall concerns two types of models (630G and 67...
  • Regulatory NewsRegulatory News

    ICH Plots Closer Collaboration With PIC/S

    In minutes from their meeting in Singapore last November, the International Council for Harmonisation (ICH) Management Committee and Assembly provide updates on a range of issues not covered in previous releases from the meeting, including the potential for closer collaboration with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) and new topics and reflection papers under development.   PIC/S Collaboration   The ICH Management Committee said it received...
  • Regulatory NewsRegulatory News

    Lilly, Novo Nordisk Fight Insulin Biosimilars With Tweaks to FDA Draft Guidance

    As Americans with diabetes continue to die because they cannot afford their insulin, two of the three insulin manufacturers in the US are doing their best to try to alter US Food and Drug Administration (FDA) draft guidance that seeks to bring more insulin competition to market. The draft guidance, unveiled last November , explains how insulin biosimilar developers may not need to conduct comparative clinical immunogenicity studies under certain circumstances. As pa...
  • ReconRecon

    Recon: FDA Places Hold on LogicBio Study; Pfizer Exits Glycomimetics Sickle Cell Disease Pact

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US biotechs fear the coronavirus outbreak will delay their China-based research ( STAT ) ( Reuters ) FDA slaps a hold on LogicBio and its gene editing plans — shares tumble ( Endpoints ) ( Fierce ) Merck walks away from KalVista, who turns their sights on HAE ( Endpoints ) Pfizer uncouples from GlycoMimetics and its failed sickle cell disease drug ( Endpoints ...
  • Regulatory NewsRegulatory News

    ICH M9 to Take Effect in EU by End of July

    About two years after first opening a consultation on the guideline, the European Medicines Agency (EMA) said Tuesday that on 30 July, the International Council for Harmonisation’s (ICH) M9 guideline on biopharmaceutics classification system-based biowaivers will take effect. The M9 guideline has been in the works at ICH since at least 2016 , and may help to avoid unnecessary in vivo bioequivalence studies. Background Two drugs containing the same drug substanc...