• Regulatory NewsRegulatory News

    Long-awaited Cures 2.0 bill unveiled

    Two years after beginning work on a follow up to the 21 st Century Cures Act , Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday introduced their Cures 2.0 bill.   The 173-page bill, intended to supercharge medical innovation, would provide new funding for programs at the US Food and Drug Administration (FDA) and Centers for Medicare and Medicaid services (CMS), as well as create the $6.5 billion Advanced Research Projects Agency for Health (ARPA-H). A co...
  • Regulatory NewsRegulatory News

    Asia-Pacific Roundup: TGA posts guidance on transition to device reclassification after consultation confusion

    Australia’s Therapeutic Goods Administration (TGA) has published guidance on the transitional arrangements for the reclassification of certain medical devices. The guidance follows a consultation that exposed the urgent need for clarification of the classification rule and definitions.   TGA’s guidance applies to medical devices that are substances introduced into the human body via a body orifice or applied to the skin. As TGA explains in the document, that definition...
  • ReconRecon

    Recon: Pfizer to allow generic versions of its COVID drug in 95 countries; Moderna, EU sign deal to donate 70M vaccine doses

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer asks FDA to authorize COVID-19 pill for unvaccinated people ( NYTimes ) As Big Pharma and Hospitals Battle Over Drug Discounts, Patients Miss Out on Millions in Benefits ( KHN ) Report says drugmakers impose unjustified U.S. price increases; spending on AbbVie drug rises $1.4 billion ( Reuters ) ( BioPharmaDive ) ( Fierce ) Pharmacy chains defend action...
  • Regulatory NewsRegulatory News

    FDA officials address common pitfalls affecting post-approval change applications

    The US Food and Drug Administration (FDA) offered some advice to help ensure smoother reviews of abbreviated new drug application (ANDA) post-approval supplements and addressed how certain changes should be categorized at the 10 November meeting of the Association for Accessible Medicines” (AAM) GRx+Biosim conference.   Officials were asked to address common issues affecting ANDA post-approval chemistry, manufacturing and controls (CMC) submissions. Agency officials ...
  • Regulatory NewsRegulatory News

    FDA revises COVID test approach after HHS reverses Trump-era LDT directive

    The US Food and Drug Administration (FDA) on Monday revised its guidance on COVID-19 tests during the public health emergency after the Department of Health and Human Services (HHS) withdrew a Trump-era policy that restricted FDA from requiring premarket review for laboratory developed tests (LDTs).   Under the updated policy, FDA said it generally expects that newly offered COVID-19 tests will have an emergency use authorization (EUA) or traditional marketing authoriz...
  • 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...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost two dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that are au...
  • 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...