• Regulatory NewsRegulatory News

    FDA Warns of Potential Contamination With Some Cardinal Health Surgical Gowns

    The US Food and Drug Administration (FDA) on Thursday advised health care providers to stop using certain Cardinal Health Level 3 surgical gowns and PreSource procedural packs due to possible product contamination.   “Cardinal Health recommends, and the FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the product...
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    Clinical Decision Support Software: Stakeholders Seek More Clarity From FDA Draft Guidance

    Industry groups, the Mayo Clinic, Regeneron and others are seeking more clarity from the US Food and Drug Administration’s (FDA) revised draft guidance on clinical decision support (CDS) software. The 27-page draft from September builds on a previous draft from 2017, with which industry also raised concerns . The latest draft clarifies the categories of CDS software subject to FDA oversight, as well as the low-risk categories of CDS software for which FDA does not in...
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    FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards

    The US Food and Drug Administration (FDA) in late December recognized the newly revised International Organization for Standardization (ISO) risk management standard for medical devices, ISO 14971:2019, along with more than 100 other consensus standards.   The move came shortly after ISO released the new version of the standard, now in its third revision, and extended FDA recognition to dozens of other consensus standards developed by ISO, the Association for the Adv...
  • Feature ArticlesFeature Articles

    How FDA Makes Decisions About REMS Requirements for Healthcare Providers

    This article discusses how companies can scrutinize regulatory precedent to best ensure healthcare providers fully understand risks associated with drugs and can safely administer them. The author covers FDA’s requirement that companies develop a Risk Evaluation and Mitigation Strategy (REMS), but highlights the lack of REMs specifics, especially where healthcare provider education and/or training is concerned. She concludes that companies should be proactive in determinin...
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    Germany’s IQWiG Finds First Tumor-Agnostic Drug Provides No Added Benefit

    Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) this week said that Bayer’s Vitrakvi (larotrectinib), approved in the EU last summer, has not been proven to provide an added benefit. Vitrakvi was the first medicine to be approved in the EU as a treatment for tumors with a specific mutation, regardless of where in the body the tumor originated. But the treatment’s safety and efficacy were evaluated in three single-arm trials, and IQWiG took issue ...
  • ReconRecon

    Recon: BioMarin Eyes $2-3M Price for Hemophilia Gene Therapy as Other Gene Therapies Test Europe’s Willingness to Cover Them

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BioMarin Explores Pricing Experimental Gene Therapy at $2 Million to $3 Million ( WSJ ) Neon Therapeutics makes one last retreat, selling itself cheap in a bargain basement M&A deal ( Endpoints ) ( BioPharmaDive ) Hedge fund veteran looks to cash in on biotech boom ( Financial Times ) Pharma execs pitch ideas at JPM to lower drug costs. None include dropping t...
  • RoundupsRoundups

    EU Regulatory Roundup: Swissmedic Streamlines Approval Process for Infectious Disease Vaccines

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Swissmedic Streamlines Approval Process for Infectious Disease Vaccines   The Swiss Agency for Therapeutic Products (Swissmedic) has changed its approach to authorization of innovative products to prevent communicable diseases. Having made the change, Swissmedic will allow companies with vaccines already approved in the European Union or United States to follow a st...
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    EMA: ISO Side Effect Reporting Format Mandatory by Mid-2022

    The European Medicines Agency’s (EMA) management board last month agreed to make the International Organization for Standardization’s (ISO) individual case safety report (ICSR) format mandatory for suspected adverse reaction reporting to EudraVigilance beginning 30 June 2022.   The format, ISO/HL7 27953-2:2011 , is based on the International Council for Harmonisation (ICH) E2B(R3) guideline on data elements for transmission of ICSRs.   “Compared to the older rep...
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    FDA Calls for Switch to New Duodenoscopes

    After clearing the first single-use duodenoscope last month , the US Food and Drug Administration (FDA) on Wednesday called on hospitals and healthcare providers to transition away from older, infection-prone duodenoscopes to newer models with disposable designs.   Over the last three years, FDA has also cleared duodenoscopes with single-use components such as end caps and elevator pieces , aimed at reducing the risk of infection, and other companies have said they...
  • Regulatory NewsRegulatory News

    NASEM Calls on WHO to Expand its Prequalification Program

    The National Academies of Sciences, Engineering, and Medicine (NASEM) on Wednesday published a new report outlining ways to strengthen regulators worldwide, and one of the report’s recommendations is for the World Health Organization (WHO) to expand its prequalification program for medical products. The prequalification program is a way for the WHO to increase access to certain HIV/AIDS, malaria, tuberculosis and other generic drugs and active pharmaceutical ingredients...
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    Government Spending Bill Tweak Means 3 More NDAs Will Become BLAs, FDA Says

    As some insulin, human growth hormone and other products transition on 23 March from new drug applications (NDAs) to biologics license applications (BLAs), the recently passed government spending bill included a further tweak to add new proteins to the transition. The NDA to BLA change effectively means that any follow-on products for these NDAs will need to win approval as biosimilars after March. The transition was created by the  Biologics Price Competition and Innov...
  • ReconRecon

    Recon: Nektar Withdraws Opioid NDA After FDA Panel Votes Unanimously Against Approval

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Nektar withdraws NDA for opioid after FDA panel's unanimous vote against it ( Reuters ) ( Endpoints ) ( Press ) FDA staff highlights neurological safety concerns with Durect's pain drug ( Endpoints ) More Than 100 Billion Pain Pills Saturated The Nation Over Nine Years ( Washington Post ) New York drug distributor exits opioids after admitting role in crisis (...