• Regulatory NewsRegulatory News

    FDA could do more to enforce ClinicalTrials.gov reporting requirements

    The US Food and Drug Administration (FDA) hasn’t been notifying most clinical trial sponsors they are in violation of reporting requirements.   That’s according to results of a Freedom of Information Act (FOIA) investigation by Reshma Ramachandran, of the Yale School of Medicine in New Haven, CT, and colleagues in a recent Viewpoint published in JAMA .   In January 2017, a final rule issued by the National Institutes of Health (NIH) determining ClinicalTrials.go...
  • Feature ArticlesFeature Articles

    Global pediatric development: Challenges, potential solutions, and opportunities

    The US and EU require sponsors to evaluate their drugs for use in children. The low prevalence of many conditions in children means sponsors commonly want to conduct one pediatric development program that satisfies the requirements of both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). However, multiregional pediatric development is challenging. This article will describe some of the challenges associated with pediatric development, offer po...
  • ReconRecon

    Recon: Philips in talks with FDA after ventilator findings; Washington state seeks billions from opioid distributors

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Dems’ plan to limit drug price inflation faces test in Senate ( Politico ) Landmark opioid trial of 3 major pharmacy chains nears its end ( Reuters ) McKesson, drug distributors face $95 billion opioid trial in Washington state ( Reuters ) ( AP ) Philips in talks with FDA after new ventilator findings – statement ( Reuters ) FDA Approves Treatment for Rare Bl...
  • Regulatory NewsRegulatory News

    This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more

    Welcome to Week 2 of This Week at FDA . We've again gathered the week’s news from (and about) FDA. Each Friday, we'll be covering agency activities and enforcement actions, filings in the  Federal Register , new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop shop for FDA updates. What do you think? We’d be happy to hear your feedback at news@raps.org. The House Committee on Oversight ...
  • Regulatory NewsRegulatory News

    Biden nominates Califf as FDA commissioner

    After months of speculation – and just days before a statutory deadline – President Joe Biden on Friday announced he would nominate Robert Califf to serve as Commissioner of Food and Drugs for the second time.   "I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making. Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work ...
  • Regulatory NewsRegulatory News

    Study: RWD not ready for postapproval prime time

    For drugs and biologics that receive accelerated approval, could information drawn from real-world data sources supplant traditional postapproval clinical trials to confirm that the therapies have benefit? Real-world data (RWD) are not yet robust enough to confirm the benefit of drugs awarded accelerated approval based on surrogate endpoints, answered the authors of a recent study.   “The findings of this cross-sectional study suggest that none of the 50 [Food and Drug...
  • RoundupsRoundups

    Euro Roundup: EU extends scope of guideline on clinical trials with genetically modified human cells

    The European Union has extended the scope of its good practice guideline on the assessment of the genetically modified organism (GMO)-related aspects of clinical trials that study human cells. Officials have revised the text to cover human cells genetically modified without viral vectors and genome edited cells.   Developers cannot use the document to determine whether cells that are genetically modified without the use of viral vectors are classified as GMOs, with off...
  • ReconRecon

    Recon: EMA recommends Regeneron, Celltrion antibodies; Ellume test recall expanded to 2M units

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna COVID-19 vaccine patent dispute headed to court, U.S. NIH head says ( Reuters ) Moderna says Covid vaccine has fewer breakthrough cases than Pfizer’s, but higher myocarditis rates in young men ( CNBC ) The Core Legal Strategy Against Opioid Companies May Be Faltering ( NYTimes ) Home virus tests recalled over false positives reach 2 million kits. ( NYT...
  • Regulatory NewsRegulatory News

    FDA touts success and challenges in biosimilar development

    A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the program in the oncology space, with less activity in other treatment areas. The costly and lengthy process of getting biosimilars approved is also a deterrent to wider uptake.   Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation...
  • RoundupsRoundups

    FDA Approvals Roundup: Eprontia, Dyanavel

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Eprontia okayed as liquid form for treating epilepsy and migraine Azurity’s Eprontia (topiramate) oral solution has been approved for treating seizures and migraines. The approval covers use of the anticonvulsant as a monotherapy and adjunctive therapy for seizures in patients aged 2 years or older and as a preventive treatment for migraine in...
  • Regulatory NewsRegulatory News

    Industry calls for technical, scope changes in ICH S12 guideline

    In response to the US Food and Drug Administration's (FDA) consultation on the International Council for Harmonisation's (ICH) S12 guideline on nonclinical biodistribution considerations for gene therapy products, two industry groups and drugmaker Novartis have suggested changes to the document.   The guideline reached Step 2b of the ICH process in June and has been released for comment by regulators, including the European Medicines Agency (EMA), to gather feedback be...
  • Regulatory NewsRegulatory News

    Friends of Cancer Research urges early dose-finding studies to reduce treatment toxicity

    Friends of Cancer Research is calling on all stakeholders in the cancer community to move away from the idea of “more is better” in drug dosing and begin to incorporate dose-finding studies into the cancer trial process.   Dose optimization is the focus of a new white paper that the group released at its 25 th annual meeting. The paper offers recommendations for performing adequate dose optimization studies in oncology, with a focus on the pre-market setting. “These...