Featured Articles

In-depth examination and analysis of regulatory and related topics, available exclusively to RAPS members.

David Nachmansohn, Nerve Gases and Electric Eels

Regulatory professionals in the pharmaceutical industry should know the historical background about David Nachmansohn and his war time effort to discover the antidote for nerve gases and other organophosphates. They may wish to learn how electric eels were used in his research. For those who work for medical device companies, electric eel cells are being studied to develop artificial cells that may be used to power future implantable devices. The article also contains general information on nerve conduction and physiology.

Categories: Features Tags:
Common Pitfalls Associated with Modifications to 510(k)-Cleared and 510(k)-Exempt Devices

This article identifies some common pitfalls companies often encounter when assessing modifications to 510(k)-cleared and 510(k)-exempt medical devices and offers approaches for performing these assessments to better ensure compliance with FDA expectations.

Categories: Medical Devices, Submission and registration, Features, US, FDA Tags: 510(k), Device Modifications
Commercial Content Development for Regulatory Compliance

Survey shows compliance gaps in promotional claims management.

Categories: Compliance, Features Tags:
Press Releases - Another Tool for Promotion?

This article discusses the regulatory oversight and recent precedent in evaluating whether or not press releases should be considered a form of promotional labeling.

Categories: Features, US, FDA, Advertising and Promotion Tags:
Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities

This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world.

Categories: Nutritional and dietary supplements, News, US, Canada, Europe, Japan, China, India, Africa, Middle East, Oceania, FDA Tags: Medical Food, Food for Special Medical Purposes
Surviving Your First FSMA Inspection

This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices.

Categories: Nutritional and dietary supplements, Manufacturing, Features, US, FDA Tags: FSMA, Food Safety Modernization Act, Inspections
Medical Foods: Guidelines for Development and Usage

This article presents the definition of medical foods, applicable regulations and the clinical trials process, including issues pertaining to study design, institutional review boards, study participants, trial managers responsibilities toward participants, data analysis and peer review.

Categories: Nutritional and dietary supplements, Features, US, FDA Tags: Medical Foods
The US Regulatory Environment for Promoting Nutritional and Healthful Aspects of Food

This article presents FDA's regulatory framework for food for human consumption and how the various legislation regarding information about nutritional content and health-related aspects of food should be presented on food labels.

Categories: Nutritional and dietary supplements, Features, US, FDA Tags: Foods, Medical foods, Dietary supplements
Targeted (Personalized) Nutrition

This article discusses the latest omics technology developments, focusing on genomics, proteomics and nutritional (metabolic) profiling and presents the main challenges for targeted nutrition and regulatory issues related to omics technologies.

Categories: Nutritional and dietary supplements, Features, FDA Tags:
China Food Safety Regulatory Framework

This article discusses changes in the regulatory control aspects of food safety in China over the past three decades, including the Ministry of Agriculture's continuing responsibility for primary agricultural food products control, the 2009 Food Safety Law1 and the newly established China Food and Drug Administration (CFDA). Health food and vitamin supplements also are discussed.

Categories: Nutritional and dietary supplements, Features, China, CFDA Tags: Food Safety
Genetically Engineered Foods and their Regulation: the Way Forward after Twenty Years of Adoption

This article reviews the US history and impact of Genetically Engineered (GE) crops over two decades, explains the federal oversight of GE crops and suggests improvements to federal oversight to ensure the safety of GE crops and greater consumer confidence in GE foods. The article also discusses public attitudes toward GE foods and the issues surrounding the labeling of those foods, including the law requiring mandatory disclosure signed by President Obama on 29 July 2016.

Categories: Nutritional and dietary supplements, Features, US, FDA Tags: Genetically Engineered Foods, GE Foods
Entering the China Market: Go-to-Market Strategies - Part 2

This is the second of a two-part series looking at best practices for medical device companies planning to enter the China market.

Categories: Medical Devices, Business Skills, Features, China Tags:
Reflections on Mergers and Acquisitions in the Healthcare Product Industry

This article outlines critical process points, seven reflections from recent Merger and Acquisition (M&A) experiences and suggests best practices for optimizing M&A due diligence from several perspectives. In addition, the article offers insight and guidance on how to act, what to look for in due diligence exercises and what areas to further explore as one partakes in due diligence activities. The content was adapted from a session at the RAPS 2015 Regulatory Convergence in Baltimore, Maryland.

Categories: Business Skills, Due Diligence, Features, Business and Leadership Tags: Mergers and Acquisitions, M&A, Due Diligence
Regulation, Substantiation Requirements and Enforcement of US Dietary Supplement Claims

This article discusses claim categories for dietary supplements and recent related regulatory development and enforcement activity to help those who market dietary supplements understand the evolving regulatory climate, legalities and substantiation requirements.

Categories: Nutritional and dietary supplements, Features, US, FDA Tags: Dietary Supplements, Nutrient Content, Recommended Dietary Allowances
International Food Regulatory Framework: the Codex Alimentarius Commission

This article reviews the mission of the of the Codex Alimentarius Commission (CAC), an international body whose mandate is to develop internationally harmonised food safety and quality standards to protect the health of consumers and ensure fair practices in the food trade.

Categories: Nutritional and dietary supplements, Features Tags: Codex Alimentarius Commission
Medical Foods Intended to Meet Distinctive Nutritional Requirements: Scientific and Regulatory Perspective

This article proposes an algorithm for investigating Distinctive Nutritional Requirements (DNRs) with the goal of guiding research and supporting the development of innovative medical food products to improve quality of care for patients.

Categories: Nutritional and dietary supplements, Features, US, FDA Tags: Medical foods
Plain Language Labelling Requirements

This article describes the requirements of the guidance document published by Health Canada on plain language labelling.

Categories: Biologics and biotechnology, Drugs, Labeling, Features, Canada, Health Canada Tags: Plain language labeling
August Feature Articles Highlight Food Regulatory Paradigms: the Right Paths for Nutrition, Health and Disease Management

Over time, the regulatory framework has evolved and continues to protect consumers and patients. However, with the unprecedented changes in demographics and advances in healthcare, it is even more important for regulatory professionals to continue to deliver timely, appropriate and affordable healthcare solutions to patients and society. And this changing healthcare paradigm with food (health) and drug (disease) systems moving closer together has created possible new opportunities and questions regarding historic pharmaceutical and nutrition "models."

Categories: Compliance, Manufacturing, Features, News, US, China, FDA, CFDA Tags: Food, Nutrition
The Innovation Imperative for Biopharmaceutical Regulatory Science: Three Emerging Trends

This article discusses how manufacturers' regulatory affairs functions could improve their conduct of regulatory science through adaptive pathways, joint scientific and health technology assessment advice and patient-centricity.

Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Features, FDA, EMA, NICE Tags: Regulatory Science
The Expanding Role of Regulatory Operations: How Technology Advances Have Equipped Operations Teams to Play a New Strategic Role

This article discusses the expanding function regulatory operations plays within organizations and how their broader responsibilities as process engineers, RIM systems experts and business analysts will play an increasing role in the organization's success.

Categories: Business Skills, Submission and registration, Features Tags: Regulatory Information Management, RIM, Regulatory Operations
Transformation Underway in how Regulatory Information is Globally Managed

This article discusses a new World Class Regulatory Information Management (WCRIM) standard and current industry status.

Categories: Features Tags: Regulatory information management
eCTD: Journey Through the Decade

This article discusses transitioning and implementing the electronic Common Technical Document (eCTD) in different regions a decade after its conceptualization. The article further discusses its impact on dossier compilation and document design practices as well as challenges faced by the pharmaceutical industry for effective lifecycle management.

Categories: Submission and registration, News, US, Canada, Europe, Japan Tags: Electronic Common Technical Document, eCTD
The Path to Successful Global Regulatory Operations: Document Management Processes and Technology Challenges

This article discusses the process and technology challenges regulatory operation organizations face as they seek to operate globally and provides recommendations for how they can begin addressing them.

Categories: Drugs, Business Skills, Project management, Features Tags: Document Management, Process Mapping, Cloud
Can Health Technology Assessment be Used to Demonstrate Significant Benefit for an Orphan Medicinal Product in the EU?

This article discusses how the conceptual grounds for significant benefit are addressed in the context of the orphan medicinal product regulations in the EU and how techniques used in Health Technology Assessment (HTA) may support the justification for the claim of significant benefit.

Categories: Biologics and biotechnology, Drugs, Orphan products, Reimbursement, Features, Europe, EMA, EC Tags:
Accelerating Global Submissions with a Six-Point eCTD Strategy

This article discusses how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. In addition, it outlines challenges specific to: large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise.

Categories: Drugs, Regulatory strategy, Submission and registration, Features, US, Canada, Europe, Japan, FDA Tags: eCTD, Electronic Submissions, Common Technical Document
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