• 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA’s Project Orbis May Expand to Singapore and Switzerland

    The US Food and Drug Administration (FDA) may expand a pilot project that allows for simultaneous drug approval decisions from US, Canadian and Australian regulators to include Singapore and Switzerland, Richard Pazdur, director of FDA’s Oncology Center of Excellence, said Tuesday at the Friends of Cancer Research's annual meeting in Washington, DC. If Singapore and Switzerland are added, Pazdur said following visits to both countries, it would further collaborations bet...
  • Regulatory NewsRegulatory News

    EMA Officials: Regulatory, HTA Advice Sped Access to Bluebird’s Gene Therapy

    Officials from the European Medicines Agency (EMA) say that advice from the agency and health technology assessment (HTA) bodies played a “key role” in speeding access to Bluebird Bio’s gene therapy Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene).   “Groundbreaking therapies such as Zynteglo present specific challenges for those who assess their benefits and risks for the initial authorisation and those who assess their value as a basis for pricing and r...
  • Regulatory NewsRegulatory News

    EC Offers Further Clarity on Clinical Trial Regulation

    The European Commission (EC) recently updated guidance on the incoming clinical trials regulation, with new questions and answers (Q&As) on requests for information (RFIs), how assessment reports will be made public and the sponsor’s responsibilities regarding changes to a clinical trial that are not substantial modifications but are relevant for supervising the trial. On the question (number 2.7) of the management of a request for information during the initial assessm...
  • ReconRecon

    Recon: Solid Biosciences Gene Therapy Study Put on Hold Again; Lonza CEO to Depart After Less Than a Year

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Google’s ‘Project Nightingale’ Gathers Personal Health Data on Millions of Americans ( WSJ ) ( Reuters ) ( NYTimes ) ( CNBC ) Shares of Amarin jump after FDA staff review on fish-oil drug ( Reuters ) ( STAT ) ( Endpoints ) Solid Biosciences gene therapy trial put on hold for second time, shares slump ( Reuters ) ( STAT ) It’s tiny biotechs — not big drug maker...
  • Regulatory NewsRegulatory News

    FDA Warns Mylan’s Indian API Facility Over Contamination Concerns

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last week to Mylan’s active pharmaceutical ingredient (API) manufacturing site in Andhra Pradesh, India, highlighting “contamination at levels above the limit” for some API batches. FDA’s inspection of the site in May and June uncovered, “Multiple contract manufacturers supplied solvents that were contaminated with [redacted], but your firm lacked documentation of which tanks were used t...