• Regulatory NewsRegulatory News

    This Week at FDA: mRNA boosters for most; Blood lancets reclassified

    Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates, the unveiling of Cures 2.0 , and lots of device updates. As usual, we welcome feedback at news@raps.org .    Friday morning, the US Food and Drug Administration (FDA) announced an expansion of the emergency use authorizations (EUA...
  • Regulatory NewsRegulatory News

    GDUFA III fiscal details emerge

    The generics industry can expect the US Food and Drug Administration (FDA) to take a more flexible approach to resource capacity planning and continue a commitment to financial transparency, according to fiscal experts from the agency who spoke at an FDA meeting earlier this week.   Although much of the framework for the third reauthorization of the Generic Drug User Fee Amendments (GDUFA III) program could be gleaned from the commitment letter released by the US Foo...
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    Industry, clinician groups have different wish lists for AI/ML-enabled device labels

    Medical device industry groups are urging the U.S. Food and Drug Administration (FDA) not to rush to create new regulatory requirements around the labeling of medical devices that incorporate artificial intelligence or machine learning (AI/ML), while clinician groups are seeking greater transparency about device algorithms and training data sets.     In total, 15 groups offered comments following a virtual public workshop held by FDA on the transparency of AI/ML-enable...
  • RoundupsRoundups

    FDA Approvals Roundup: Besremi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Besremi okayed for rare blood disease PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft injection) has been approved for treating adults with polycythemia vera, a blood disease caused by a JAK2V617F mutation that results in overproduction of red blood cells (RBCs).   The monopegylated, long-acting interferon alfa-2b reduces excess RBCs...
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    FDA inspection turns up more problems for Philips Respironics

    Hundreds of thousands of complaints from users of Philips Respironics’ breathing assistance devices have been inadequately addressed by the firm, according to recent information released by the US Food and Drug Administration (FDA). The release of an inspection report and FDA’s accompanying statement provides more detail on what Philips knew, and what the firm did – or did not do – to remedy known problems with degradation of foam components in its breathing devices.   ...
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    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...
  • 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

    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

    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

    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...
  • Regulatory NewsRegulatory News

    Real-world evidence from EHR supports antimicrobial resistance fight

    An automated system that extracts real-world data from the electronic health record is as efficient as manual data extraction in gathering real-world data to support research into antibiotic resistance, according to a new report on research supported by the US Food and Drug Administration (FDA).   The data extraction project, supported by FDA through the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), began with investigators from the Johns H...