• RoundupsRoundups

    Euro Roundup: MHRA proposed 10% jump in fees, further increases to some services

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) would increase all its statutory fees by 10% as part of wider proposals that represent the agency’s most significant shift in fees and funding in years.   MHRA proposed a 10% increase in all fees after calculating that the rate is in line with the rise in staff costs – which account for half of the agency’s spending – since it last reviewed its rates in 2016. Costs for other outlays, such as IT, laborato...
  • Regulatory NewsRegulatory News

    Groups weigh in on FDA’s licensing rules for 3PLs and distributors

    Supply chain trading partners expressed broad support for the US Food and Drug Administration’s (FDA) proposed rule on uniform licensing standards for wholesale distributors and third-party logistics providers (3PLs), which are set to replace the current patchwork system of state licensing standards. The standards implement aspects of the Drug Supply Chain Security Act (DSCSA) and are meant to plug holes in the country’s pharmaceutical supply chain.   The generic dru...
  • Regulatory NewsRegulatory News

    Industry experts tout potential for master protocols in pediatric clinical trials

    Using master protocols in pediatric clinical trials could speed the development of drugs for pediatric indications that already have development programs for adults, according to a recent paper written by industry representatives and published in Therapeutic Innovation & Regulatory Science .   A master protocol framework would potentially have “great benefit” because stakeholders could use shared control groups, operate more efficiently in the clinical setting and use...
  • Regulatory NewsRegulatory News

    Patient preference information: Researchers offer insights on medical device clinical trial design

    The US Food and Drug Administration (FDA) has increasingly called for the inclusion of patient preference information (PPI) to inform its regulatory decision-making for medical devices. A recently published report offers insights on the opportunities to leverage PPI, such as how to maximize stakeholder engagement, identifying novel endpoints and statistical considerations.   The article, published in Therapeutic Innovation & Regulatory Science on 27 August, looks at ...
  • ReconRecon

    Recon: Sanofi expects EU decision on COVID booster within weeks; FDA reviewers unconvinced ahead of second Amylyx adcomm

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Lifts Hold on Sarepta’s DMD Trial Following Protocol Adjustments ( Biospace ) ( Fierce ) ( Pharma Letter ) Updated COVID boosters ready in U.S. this week, White House says ( Reuters ) FDA approves durvalumab for locally advanced or metastatic biliary tract cancer ( FDA ) ( Biospace ) FDA expands approval for Vertex's CF drug Orkambi to infants under two ye...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA seeks feedback on request to lift ivermectin restrictions

    Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on whether to allow off-label use of the antiparasitic drug ivermectin, following a request by an applicant who branded the current restrictions as “irrational, irresponsible, reckless, negligent and possibly criminal.”   TGA limited off-label prescribing of ivermectin to dermatologists, gastroenterologists, hepatologists and infectious diseases specialists in 2021 in response to an increase in pres...
  • Regulatory NewsRegulatory News

    Clinical trials: Real-world data plays early role in efforts to increase diversity

    The use of real-world data (RWD) to help design clinical trials is nothing new but increasingly it is being used early in the process to boost trial diversity and inclusion.   “Data really is the bedrock of how we’re able to increase representativeness in clinical trials as we go forward,” said Christina Mack, PhD, Chief Scientific Officer of IQVIA Real World Solutions, a company providing analytics and technology solutions to the life sciences industry.   Conversa...
  • Feature ArticlesFeature Articles

    Nutrition and health claims in the European Union in 2022

    Nutrition and health claims are widely used on food labels and may positively influence consumer perceptions and intentions to buy food. Regulation (EC) 1924/2006 on nutrition and health claims aims to ensure claims are clear, scientifically substantiated, and supports consumers to make informed decisions. The European Commission (EC) is working to introduce a legislative proposal on nutrient profiles in 2022 to restrict the use of claims on foods high in saturated fat, su...
  • This Week at FDAThis Week at FDA

    This Week at FDA: ACIP signs off on bivalent boosters

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the agency’s decision to authorize bivalent COVID-19 vaccine boosters from Pfizer-BioNTech and Moderna. On Thursday, a key Centers for Disease Control and Prevention (CDC) panel voted 13-1 in support of both modified boosters.   On Wednesday,...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    How to learn about healthcare product labeling and why it matters for regulatory professionals

    “It all comes down to labeling. It is all about labeling.”  So says Cathleen O’Connell, architect of RAPS new Online University course Pharmaceutical Labeling: Introduction to an Essential Function . She’s also the author of Essentials of Healthcare Product Labeling , a RAPS publication that dives into the subject. Cathleen has more than 20 years of experience in healthcare product labeling as both a practitioner and an educator.  O’Connell joined RAPS for an interv...
  • Regulatory NewsRegulatory News

    FDA: Criminals using EU hubs to ship illicit medical products into the US

    The US Food and Drug Administration (FDA) on Thursday said that bad actors are using shipping hubs in the European Union to get around its inspection system to transport illicit medical products to the US. Key stakeholders, including FDA and EU officials, plan to meet later this month to strategize on how to stop them.   In a 1 September blog post , Cathy Hermsen, FDA assistant commissioner for criminal investigations, and Ritu Nalubola, director of FDA’s Europe offic...
  • Regulatory NewsRegulatory News

    Pharma groups: FDA is exceeding its authority in risk management plan guidance

    The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of active pharmaceutical ingredients (APIs) as well as prescription drug manufacturers to submit risk management plans (RMPs) to avert drug shortages.   This requirement could impose the very drug shortages it is designed to prevent, instead of just targeting those products at risk of drug shortage, pharmace...