• Regulatory NewsRegulatory News

    FDA to Allow Online Submissions of Orphan Designation Requests

    As part of work building on the US Food and Drug Administration’s (FDA) orphan drug modernization plan from 2017 , the agency said Friday that later this year it will move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests. The shift to online submissions will ease the process of making orphan drug designation requests, which are currently  mailed into the Office of Orphan Products Development (OOPD) on a CD. ...
  • Regulatory NewsRegulatory News

    EMA Suspends Picato Authorization, Confirms Limits for High-Strength Estradiol Creams

    The European Medicines Agency (EMA) is following a recommendation from its Pharmacovigilance Risk Assessment Committee (PRAC) this week to suspend the marketing authorization for Leo Pharma’s actinic keratosis cream Picato (ingenol mebutate), while the agency investigates reports of increased rates of skin cancer associated with the drug.   The suspension follows PRAC’s investigation of Picato’s safety last year after multiple studies showed a higher rate of skin can...
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    MAPP Further Explains FDA Process for Reviewing REMS Assessment Reports

    The US Food and Drug Administration (FDA) last month offered a new Manual of Policies and Procedures (MAPP) to explain how the Center for Drug Evaluation and Research (CDER) reviews risk evaluation and mitigation strategy (REMS) assessment reports submitted to the agency. Although the statute does not specifically describe how companies should conduct their assessments, the agency has released two draft guidances (one on survey methodologies and another on planning and ...
  • Regulatory NewsRegulatory News

    'CurAll' or 'Bestmab': FDA to Study How Proprietary Names Affect Perceptions

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is planning a study to investigate how proprietary drug names affect consumers’ and/or healthcare providers’ perceptions and whether they might overstate the efficacy of a drug. During FDA’s prescription drug approval process, sponsors propose proprietary names for their products, which are reviewed by the Office of Drug Safety, the relevant medical office and OPDP. OPDP reviews nam...
  • ReconRecon

    Recon: FDA Panel Split on Durect Non-Opioid Painkiller; Novo’s Ozempic Gains CV Indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel split over approval of Durect's non-opioid painkiller ( Reuters ) ( Endpoints ) Republican FTC commissioner says she supports Medicare negotiating drug prices ( The Hill ) ( STAT ) Novo Nordisk's diabetes pill Rybelsus to be covered by Express Scripts ( Reuters ) Novo Nordisk's blockbuster Ozempic wins FDA label boost with CV indication ( Endpoints )...
  • 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...