Featured Articles

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

FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective

Despite all of the public discussion about FDA's enforcement approach in the off-label promotional arena, the agency continues to take action against any perceived unlawful promotion. Recently, FDA issued Notice of Violation letters to drug companies for promoting their investigational new drugs as safe and effective.

Categories: Drugs, Features, US, FDA, Advertising and Promotion, Communication Tags: Notice of Violation
Global Regulatory Submissions: How to Build a Plan That Works Everywhere, Every Time

This article discusses today's fast-changing global regulatory environment, including flexible submission strategies and strong, centralized teams required to achieve successful approvals and product launches.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, FDA, EMA Tags:
China Food and Drug Administration Issues New Requirements for Clinical Trial Applications and New Drug Applications

This article discusses the growth of China's pharmaceutical market, background of the global use and acceptance of the Common Technical Document (CTD), outlines the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs.

Categories: Drugs, Clinical, Submission and registration, News, China, CFDA, ICH Tags: Electronic common technical document, eCTD, Clinical trial application, CTA,
Global Regulatory Strategy

This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, US, Canada, Europe, Japan, FDA, EMA, Health Canada, MHLW, PMDA Tags: Priority Review, Accelerated Approval, Breakthrough Designation, Fast Track Designation, Conditional Approval, PRIME, Adaptive Licensing, Accelerated Assessment, Sakigake
Standardization Best Practices for Managing Regulatory Processes: Part 1

This article reviews the most common standardization challenges, including inconsistent data definition, data capture and processes and suggests system consolidation and automation will only succeed if data is standardized and processes are harmonized.

Categories: Regulatory strategy, Features, Communication Tags: Standardization, Data Capture, Processes
Changing Times of Advertising and Promotion, Hot Topics and a Preview of October

The following is a summary of feature articles posted throughout September with links and a preview of what's to come in October.

Categories: Features, Advertising and Promotion, Communication Tags:
Do Recent First Amendment Court Developments Deal a Blow to the Government?

This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications.

Categories: Drugs, Government affairs, Features, US, FDA, Advertising and Promotion, Communication Tags: Amarin, Pacira, Vascular Solutions, First Amendment, Off-label promotion
The Importance of Internal Systems to Support Social Media Campaigns

This article discusses the importance of internal systems to ensure social media and marketing campaigns are in compliance with FDA requirements.

Categories: Features, US, FDA, Advertising and Promotion Tags: Social Media
The Path Less Followed - Submission Guidance for Responsive Design Websites

This article recommends an operational path forward for streamlining the development and review of "responsive design" websites for pharmaceutical products promotion.

Categories: Submission and registration, Features, US, FDA, Advertising and Promotion Tags: Responsive design websites
Regulatory Advertising and Promotion: Exploring the Past and Present to Understand the Future

This article provides a chronological overview of legislative milestones shaping the landscape of regulatory advertising and promotion. It reviews standards for prescription drug promotion and summarizes important cases involving off-label promotion with the purpose of showing that while interpretation for what is considered truthful and not misleading has been changing, regulations defining them have not changed.

Categories: Drugs, Features, US, FDA, Advertising and Promotion Tags: Off-Label Promotion, Amarin, Pacira, Vascular Solutions
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
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