• Regulatory NewsRegulatory News

    Convergence: Manufacturers failing to grasp ‘step change’ in requirements under MDR

    Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.   Butcher, principal regulatory consultant at medical device contract research organization NAMSA, used his presentation at the event to discuss his practical experience of the challenges the European Union legislation is creating for the industry. The session focused...
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    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
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    Convergence: EMA study reveals need for RWE framework, submission structure

    The European Medicines Agency (EMA) has identified a need for more consistency in how real-world evidence (RWE) is submitted, Xavier Kurz told attendees at RAPS Convergence 2021.   Kurz, the head of surveillance and epidemiology at EMA, said the agency reached the conclusion after analyzing the use of RWE in applications for marketing authorization and extension of indication in 2018 and 2019. The study, preliminary findings from which were shared at RAPS Convergence 2...
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    Convergence: Regulatory considerations in advancing gene and cellular therapies

    When developing a regulatory submission for a gene or cellular therapy, it’s essential to keep the basics in mind, such as how to demonstrate the product’s identity, purity, and potency, Haroon Hashmi, PhD, told attendees at RAPS Convergence 2021.   “Even when we think about these complex technologies -- new emerging technologies -- certain regulatory principles always stay in place,” said Hashmi, senior vice president at Ziopharm Oncology, which has developed the Slee...
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    Convergence: First-year experience with Japan’s amended medical device rules

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is providing priority review for certain innovative medical devices and has implemented a post approval change management process to allow for continuous improvement of medical devices.   The changes are part of the Amendment of the Pharmaceutical and Medical Device Act (PMD Act), which was implemented in September 2020. Officials from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the PMDA provided a...
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    HMA-EMA plans real-world metadata framework for regulatory decision-making

    Officials at the Heads of Medicines Agencies – European Medicines Agency (HMA-EMA) are moving forward with an effort to create a usable catalogue of metadata to aid the scientific community in identifying real-world evidence that can inform regulatory decisions.   Metadata is defined generally as “a set of data that describes and gives information about other data” and can be further subcategorized by generation, location, ownership, and governance of the data; process...
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    EU committee considers antimicrobial incentives, repurposing oncology drugs

    During a recent joint meeting of the European Union (EU) Directors for Pharmaceutical Policy and the Pharmaceutical Committee, members debated potential ways to combat antibiotic resistance and improve access to oncology medicines through the repurposing of older or generic medications.   The meeting, held via video conference on 08-09 July 2021, was co-organized and co-chaired by the Slovenian Presidency of the Council of the EU and the European Commission, with atten...
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    FDA proposes to refuse Intarcia’s exenatide combo product NDA —again

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has told Intarcia Therapeutics it is proposing to refuse a new drug application for their type 2 diabetes drug-device combination product ITCA 650.   In a notice posted in the Federal Register , the agency said Intarcia can request a hearing from FDA on the proposal, but if the hearing is waived or it is determined the reason for the hearing isn’t sufficient, FDA will move forwa...
  • ReconRecon

    Recon: Novartis' Leqvio nabs NICE nod; HebeCell makes a foray into CAR-NK space

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US When Will the Delta Surge End? ( NYT ) Why can’t America fix its Covid-19 testing problems? ( VOX ) Vaccination Rates Rose In August As COVID Cases Surged Due To The Delta Variant ( NPR ) First vaccination doses up 17 percent since Pfizer approval: analysis ( The Hill ) Companies eye financial penalties for unvaccinated workers ( The Hill ) America has waste...
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    Recon: Gruber and Krause to leave CBER; Sanofi refiles with FTC on $3.2B Translate Bio buyout

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Percentage of Americans who say they won't get vaccinated drops to record low in new poll ( The Hill ) US demand for COVID-19 antibody treatments rising fast ( PMLive ) CDC Staff Floats 'Risk-Based Approach' to Potential Booster Doses ( MPT ) CDC panel unanimously endorses full approval of Pfizer’s Covid vaccine for people 16 and older ( CNBC ) Nearly 1 m...
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    Recon: Baxter in late-stage talks for $10B Hillrom buy; Catalent drops $1B for gummy vitamin maker

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID-19 Deaths And Hospitalizations Continue To Rise In The U.S. ( NPR ) HHS Lifts Pause on Lilly's Monoclonal Antibody Combo, Sort Of ( MPT ) U.S. CDC advisers vote in favor of Pfizer COVID-19 vaccine ( Reuters ) Baxter in late-stage talks to buy Hillrom for about $10B: WSJ ( MedTech Dive ) Reimbursement begins slowly for Biogen’s expensive Alzheimer’s ...
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    EMA goes all in on big data

    The European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) have issued an ambitious workplan for a joint steering group to tackle issues related to big data in healthcare and medicines development.   The steering group’s 2021-2023 work plan, adopted in June and published Friday, “aims to increase the utility of big data in regulation, from data quality through study methods to assessment and decision-making,” according to EMA’s big data webpage...