• Feature ArticlesFeature Articles

    Regulatory Strategist Toolbox: 2018 FDA Regulatory Intelligence Briefing

    If you thought 2017 had a lot of changes, 2018 was even busier (and 2019 seems to be shaping up just the same if not busier). This article explores the major changes during 2018 including guidance documents drafted and finalized, new legislation, other areas of interest and some tools to help you explore additional areas.   Strategic Policy Areas (Drug/Biologic Specific Only) Summary   The following four priority areas were identified in FDA’s 2018 Strategic Polic...
  • Feature ArticlesFeature Articles

    Regulating Software as a Medical Device in the age of Artificial Intelligence

    This article summarizes the current and proposed regulatory landscape for software as a medical device (SaMD) with artificial intelligence and machine learning capabilities. The author provides definitions for SaMD, categorization and testing features and how to approach and adjust regulatory pathways for SaMDs that “learn” by using real-world evidence to continuously adapt and improve and, therefore, may need to be re-submitted for a new premarket approval due to changes ...
  • Feature ArticlesFeature Articles

    Investigating Data Integrity Failures for Manufacturing Changes: Human Factors

    This article discusses the importance of considering human factors when investigating data integrity failures. The author reviews the potential for human factors to cause data integrity failures, describes how people can discover solutions for preventing data integrity failures and recommends ways to reduce failures.   Introduction   More than 90% of data integrity failures are considered to be unintentional with no apparent efforts to violate or falsify data. Ho...
  • Feature ArticlesFeature Articles

    Protecting the Healthcare Infrastructure: Global Cybersecurity Compliance

    This article reviews past and current efforts to protect medical devices and other connected healthcare infrastructure from security breaches. The authors cover recent regulatory efforts in Australia, Canada, China, Europe, Japan and the US aimed at enhancing cybersecurity and industry’s efforts in cybersecurity regulatory compliance to protect patients as well as healthcare infrastructure.   Introduction   What are the Issues?   The US healthcare and public ...
  • Feature ArticlesFeature Articles

    Will the FDA Precertification Pilot Program Work?

    This article discusses the new pilot program from FDA that aims to make it easier for qualified companies to move software through premarket review, while better leveraging postmarket data collection, and whether the program will work in practice as planned.   Introduction   Digital health products often fall into a class of their own. With the tsunami of Software as a Medical Device (SaMD) products soon to go through the approval process, FDA is proactively lookin...
  • Feature ArticlesFeature Articles

    Global Medical Device Cybersecurity Compliance Requirements

    This article discusses compliance requirements to maintain global medical device cybersecurity. The author provides examples of recent cybersecurity breaches and also reviews efforts made by regulatory agencies in the US, Australia and China to be proactive in encouraging better cybersecurity, offering tools and tips to help a variety of healthcare organizations to achieve better cybersecurity.   Introduction   Cybersecurity can be defined as a process for preventi...
  • Feature ArticlesFeature Articles

    Communication With the Chinese Center of Drug Evaluation (CDE) During Drug Development

    This article provides an English translation of the Chinese Center for Drug Evaluation’s (CDE’s) regulations for communication with CDE on meeting management practices. The author describes standard procedures for requesting, preparing for, scheduling, conducting, rescheduling/cancelling and documenting meetings or other correspondence with the agency.   Introduction   In October 2018, China’s national drug regulatory body, the National Medical Products Administrat...
  • Feature ArticlesFeature Articles

    Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

    This article discusses the scope and purpose of the special designation for Regenerative Medicine Advanced Therapies (RMAT) created by the passage of the 21 st Century Cures Act . The authors explain the benefits expected to be realized with RMAT, such as keeping the US globally competitive in the field. They provide a tally of products receiving the special designation to date and a current count, by year, of products for which RMAT designation has been requested.   ...
  • Feature ArticlesFeature Articles

    FDA’s Steps Toward a new Review Framework for Medical Devices Using Artificial Intelligence Algorithms

    This article provides a high-level overview of FDA’s proposed framework specifically tailored to promote the development of medical devices using artificial intelligence algorithms; it is not intended to provide a detailed explanation of the proposal, which is very technical.   Introduction   On 2 April 2019, the Food and Drug Administration (FDA) issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to pro...
  • Feature ArticlesFeature Articles

    The African Pharmaceutical and Medical Industry: Growth Factors

    Africa is one of the fastest growing economies in emerging markets. This article discusses some important aspects of this growing economy and how the local governments, as well as pharmaceutical companies can benefit from each other.   Introduction to Emerging Market   In the last two decades, various multinational pharmaceutical companies have entered and established themselves in one or more of the emerging markets. The Brazilian, Chinese and Indian markets grew ...
  • Feature ArticlesFeature Articles

    Biosimilars, Regulatory Science, Cell and Gene Therapy Guidance and China’s Regulatory Landscape

    April features took an in-depth look at biosimilars from a global perspective, the need to update regulatory science to include the use of Minimal Residual Disease (MRD), recent changes to China’s healthcare regulatory authorities and healthcare policy administration and the importance for manufacturers and regulators to ensure manufacturing controls are in place to sustainably produce regenerative medicines.   Biosimilars   Gowri Sukumar focuses on global regulati...
  • Feature ArticlesFeature Articles

    Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry

    Addressing manufacturing controls for the cell and gene therapy industry, this article discusses criticality of establishing Chemistry Manufacturing Controls (CMC) Readiness, Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for cell and gene therapy products. The author suggests manufacturers need sound drug development and manufacturing facility plans covering a product’s lifecycle and should establish sustainable manufacturing control strategies ...