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    Medical Device Marketing Under Substantial Equivalence—FDA Clearance and USPTO Patent Considerations

    This article focuses on medical device regulation by the US Food and Drug Administration (FDA) and medical device patent protection by the US Patent and Trademark Office (USPTO). The authors state most companies operating within the medical device space do not provide for sufficient interaction between those responsible for FDA approval and those responsible for patent protection. Because a “leak” of information about an invention during the FDA approval process before a ...
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    The Regulatory Strategist Toolbox: Clinical Endpoint Analysis Tools

    One of the critical parts of assembling a product’s “Strategy Playbook” or “Clinical Development Plan” is the researching and planning of clinical endpoints. This article discusses how to research endpoints, including tools to research them, how to organize the information and how to present the intelligence back to the team. Endpoints are measures intended to reflect the effects (efficacy endpoints) or safety (safety endpoints) of a drug or device. They include assessme...
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    Australian Regulatory Framework of Over-the-Counter and Complementary Medicine

    This article discusses Australia’s regulatory framework for Over-the-Counter (OTC) and complementary medicines as defined by the Medicines and Medical Devices Regulation (MMDR) and provides medicine-related classifications, types of postapproval changes, labeling, stability and advertising requirements. The author recommends measures for reinforcing regulatory compliance of complementary medicines. Introduction OTC and Complementary Medicine Australia has been acknowle...
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    Regulatory Challenges in Mobile Medical Applications

    This article presents the challenges associated with the regulation of mobile medical applications compared to computer software. The authors identify the differences between mobile applications and computer systems to determine the practical challenges of regulating these mobile applications as Software as a Medical Device (SaMD). This article also highlights various principles that can be followed to ensure patient safety and wellness by mobile application manufacturers...
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    Clarifying FDA’s Off-Label Promotion Efforts

    This article discusses off-label promotions and subsequent changes in related FDA guidances derived from the agency’s approaches to two First Amendment cases and recently enacted state laws regarding off-label communication. The authors suggest that Federal court challenges, newly enacted laws and the value of off-label information from a clinical practice and health economic perspective have pressured FDA to “fine-tune” interpretation of its regulations to make them more...
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    Canadian Drug Advertising Regulations

    This article discusses Canadian drug advertising regulations and focuses on applicable laws from Health Canada and various other Canadian regulatory bodies. The author stresses the importance of understanding what Canada considers advertising, the limitations on marketing efforts and whether healthcare product advertising is aimed at healthcare providers, patients or general consumers for companies outside of Canada who want to enter the Canadian market and advertise thei...
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    Pregnancy and Lactation Labeling Rule: Strategies for Updating Prescription Drug Labels for Compliance

    This article outlines the process by which a sponsor can update a previously approved United States Prescribing Information (USPI) to be compliant with FDA’s Final Rule Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (79 FR 72063) published in 2014. The Final Rule introduced significant changes to the format of the USPI for prescription drug and biological products. Commonly referred ...
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    Benefit-Risk Management: the Role of Patient Input

    This article provides an overview of the emerging science of “patient input” in the drug development process in the US. The authors summarize key, multi-stakeholder initiatives, discuss and explain forthcoming guidance from the US Food and Drug Administration (FDA) and describe potential methods—both quantitative and qualitative—for collecting patient input to address specific regulatory questions concerning benefit-risk assessment and risk management across a medical pro...
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    Risk Management, Policy Framework, EU MDR and EU IVDR, and Global Orphan Drug Regulations

    Feature articles over the past weeks have focused on risk management, the global regulatory framework, including next generation cancer vaccines, drug delivery combinations and pediatric plans, the latest on EU MDR and EU IVDR implementation and global orphan drug regulations. Risk Management Recognized drug safety and risk management expert Elaine Morrato discusses the intersection of emerging implementation science and regulatory science innovation and how together...
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    Pharmaceutical Risk Management in the 21st Century Cures Era

    This article discusses the intersection of emerging implementation science and regulatory science innovation and how together they may advance pharmaceutical risk management in the US. The author touches on topics from implementation science, including approaching risk management as an adaptive, rapid-cycle process embedded within a learning health system; dissemination design for better adoption and sustainability of the intended risk mitigation behavior(s); and framing ...
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    Regulatory Strategist’s Toolbox: Global Orphan Drug Regulations, Requirements and Designation Requests

    This article defines “orphan drugs,” briefly outlines the requirements for orphan drug designation, discusses global orphan designation requirements, databases, processes and what new countries are exploring an Orphan Drug Act or regulation. The author also provides global orphan drug resources to aid in preparation of an application. Introduction An orphan drug is a product for use in the treatment of a rare disease. Rare diseases are those that occur infrequently or r...
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    Risk Management in the Digital Healthcare Sector

    This article discusses the convergence of the information technology and the healthcare industries and the increased use of digital products connecting patients and healthcare professionals. The author reviews issues surrounding risk management, including the risk potential for “telemedicine” devices, regulatory expectations and cybersecurity concerns. Introduction The medical device and pharmaceutical industries have embarked on an advantageous, evolutionary journey fo...