• Regulatory NewsRegulatory News

    EMA Finalizes Clinical Development Guideline for New Gout Treatments

    The European Medicines Agency (EMA) on Thursday issued a guideline setting its expectations for the clinical development of new urate-lowering therapies (ULT) and anti-inflammatory drugs to treat gout.   The 14-page guideline comes less than a year after EMA’s Committee for Medicinal Products for Human Use (CHMP) released the draft version for consultation and seven years after the agency published a concept paper highlighting the need for such guidance.   Whil...
  • Regulatory NewsRegulatory News

    FDA Advisory Committee Votes Unanimously in Favor of Expanding Amarin’s Vascepa Label

    The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Thursday voted 16-0 to recommend that the agency expand the label of Amarin’s Vascepa (icosapent ethyl), a derivative of fish oil, to add an indication on reducing the risk of cardiovascular events. The meeting was closely watched because the expanded label could push Vascepa, which six years ago received a negative opinion from this same committee on an expanded label, to blockbuster status. In 2018, Va...
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    Teva to Re-enter Pediatric Cancer Drug Market After Shortage Concerns

    Teva Pharmaceuticals said Wednesday afternoon that it will return to manufacturing the pediatric cancer drug vincristine after it previously left the market, which coupled with Pfizer manufacturing issues led to a shortage of the drug. Pfizer, which controls about 97% of the vincristine market, said in a letter to customers last month that it expects to return to full supplies of the drug by January after an increase in demand for the injectable. Rep. Anna Eshoo (D...
  • Regulatory NewsRegulatory News

    FDA Warns Dollar Tree for Importing Unsafe OTC Drugs

    The US Food and Drug Administration (FDA) on Thursday released a warning letter sent to the owner of Dollar Tree and Family Dollar stores for importing over-the-counter (OTC) drugs from contract manufacturers that had been banned from importing products to the US. The warning letter says that the firm received acne treatment pads from China-based Shanghai Weierya Daily Chemicals Factory, which was placed on import alert in September 2017 and received a warning letter ...
  • ReconRecon

    Recon: FDA Panel Votes Against Jardiance as Add-On to Insulin in Type 1 Diabetes; Congo Begins Rollout of J&J Ebola Vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel votes against Lilly-Boehringer Ingelheim's diabetes drug ( Reuters ) ( Endpoints ) ( Pink Sheet -$) ( Press ) AstraZeneca, Merck win red carpet treatment at the FDA as a 3-time loser seeks speedy OK for rare tumors ( Endpoints ) ( Press ) Sarepta picks up a slate of preclinical gene therapy programs, seeding new StrideBio deal with $48M upfront ( Endp...
  • Feature ArticlesFeature Articles

    Big Data and its Impact on the Pharmaceutical Industry

    This article defines “big data” and discusses its impact on the pharmaceutical industry regarding its application and usefulness. The author covers several areas in which big data has had a profound impact, such as in genomics, clinical trial monitoring, clinical monitoring and pharmacovigilance. He concludes by touching on big data and its relationship to the regulatory professional.   Introduction   The internet has provided a convenient way to share information ...
  • RoundupsRoundups

    EU Regulatory Roundup: Health Group Raises Concerns About Delays to Clinical Trial Portal and Database

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EU Health Group Raises Concerns About Delays to Clinical Trial Portal and Database   The European Parliament’s public health committee has raised concerns about the delayed rollout of a clinical trial portal and database. Committee members made the comments shortly after the European Medicines Agency (EMA) provided an update on the repeatedly delayed system.   W...
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    FDA Finalizes Guidance on Handling Device Export Certificate Denials

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining how the agency handles denials of requests for a certificate to foreign government (CFG) for medical devices and how to request a review when a CFG is denied.   Such certificates are used to assure foreign governments that a device being exported complies with US regulations, such as the Quality System Regulation (QSR).   The eight-page guidance finalizes a draft version issued i...
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    Researchers Call on FDA to Rethink Guidance Allowing Use of Surrogate Outcomes

    The US Food and Drug Administration (FDA) needs to reconsider its use of surrogate outcomes in some guidance documents on developing treatments for infectious diseases, researchers from Harvard and George Washington University School of Medicine wrote in a review published Tuesday in JAMA Internal Medicine . The review evaluated 22 FDA guidance documents, which included recommendations for pivotal clinical trials in 27 disease indications. For six indications (22%), on...
  • Regulatory NewsRegulatory News

    WHO Seeks to Expand Access to Insulin With Prequalification Program

    As only about half of the 65 million people worldwide with Type 2 diabetes who need insulin can access it, the World Health Organization (WHO) on Wednesday announced the creation of the first prequalification program for insulin manufacturers. The pilot prequalification program seeks to expand the pool of quality insulin products via an evaluation to ensure their quality, safety and efficacy. WHO said the program is limited to insulin products either approved by a st...
  • ReconRecon

    Recon: Vertex CF Drugs Win Coverage in Wales; Merck Buys San Diego Biotech Calporta for up to $576M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA still allowing secret reports on medical devices ( Star Tribune ) NY insurance regulator notifies opioid makers, distributors of enforcement action ( Reuters ) Google’s ‘Project Nightingale’ Triggers Federal Inquiry ( WSJ ) ( STAT ) Lawmakers Scold Google’s ‘Project Nightingale’ Over Health-Data Privacy ( WSJ ) ICER draws new gene therapy pricing framewor...
  • Feature ArticlesFeature Articles

    Regulatory Cybersecurity Requirements for Medical Devices

    This article discusses the relevance of cybersecurity to the healthcare industry, cybersecurity requirements presented by governing bodies and industry best practices for medical devices. Introduction Advancements in medical device technology has allowed for services, initiatives and changes in healthcare delivery to evolve at a break-neck pace. Smartphones are increasingly integrated into patient care planning, providing internet connectivity to share data with Heal...