Featured Articles

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

Insulin: The First Truly Miracle Drug

This article will discuss diabetes, the process of the discovery of insulin and provide brief biographies of two intrepid people involved.

Categories: Biologics and biotechnology, Research and development, Features, Canada Tags: Diabetes, Insulin, Drug Discovery
The Measure of Quality

This article details how regulatory professionals can measure the quality of the outputs generated from the quality department. Additionally, the terms Quality Assurance (QA), Quality Control (QC) and quality management are often erroneously used interchangeably. Included are details about how these terms differ.

Categories: Quality, Features Tags: Quality assurance, Quality control, Quality management
A Summary of 10 Years of Paediatric Legislation in the European Union

This article summarizes 10 years of experience with paediatric regulations in the EU.

Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, Features, Europe, EMA, EC Tags: Paediatric Legislation, Paediatric Investigation Plan, Paediatric Committee, (PDCO)
Automation Best Practices for Managing Regulatory Processes: Part 2

This article shares observations from regulatory experts on how to compliantly and efficiently manage change events, such as label or manufacturing changes, with health authorities globally.

Categories: News, Communication Tags:
How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Categories: Medical Devices, Manufacturing, Features, ISO Tags: ISO 13485:2016, Quality Management System
Why Respond to an FDA 483 in a Timely Manner

We reviewed some warning letters issued by the US Food and Drug Administration (FDA) this year that reminded us of the 1981 hit song by Styx, "Too Much Time on My Hands." Two companies had received a FDA 483 List of Observations following an inspection.1, 2 The companies accordingly responded to the agency within 15 business days; however, they also provided subsequent substantive responses to the FDA 483 outside of the 15-day window. In the warning letters, FDA acknowledged the companies' initial responses, but noted the subsequent responses were untimely and not reviewed by the agency as it considered potential next enforcement steps.

Categories: Compliance, Regulatory strategy, Features, US, FDA, Communication Tags:
Recent Trends in Prescription Drug Promotion Enforcement

This article presents brief summaries of the 2016 enforcement letters, analyzes how different data cuts, groupings and correlations to relatable events can be constructed to explain different trends and introduces some key events along the enforcement letter timeline.

Categories: Features, US, FDA, Advertising and Promotion, Communication Tags:
RAPS Regulatory Convergence - 2016 Hot Topic Review

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions covering innovation and technology, Zika, real world evidence, patient access to innovative medicines and recent developments in off-label promotion.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Labeling, Research and development, Submission and registration, News, US, Europe, Japan, FDA, MHLW, PMDA, Advertising and Promotion, Communication Tags: Regulatory Convergence, 2016 RAPS
Process Validation Review: How Many Ways Can You Bake a Pie?

This article explains process validation in a fun way using pie baking as an analogy.

Categories: Drugs, Quality, FDA Tags: Process validation
You Only Get One Chance to Make a First Impression - Do It Right The First Time (DIRTFT)

This article speaks to the unique opportunity "start-up" organizations have to create and implement robust compliance and quality system paradigms and systems "right the first time" to accommodate growth and prevent later compliance issues.

Categories: Medical Devices, Compliance, News, US, FDA Tags:
Draft CFDA Guidance on Drug Data Management Practices

The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance.

Categories: Clinical, Manufacturing, Preclinical, Research and development, News, China, CFDA Tags: Data Management
The Evolving Role of the Regulatory Professional

This article discusses the multifaceted role of regulatory professionals who must guide internal company functions from product formulation and analytical development, to manufacturing, supply chain, quality control, clinical and non-clinical science and statistics. The role includes understanding the changing regulatory environment, interpreting laws and regulations and generating relevant data to support compliance.

Categories: Business Skills, Features Tags:
A Regulatory Experience of a Lifetime

This article covers a unique regulatory experience in the pharmaceutical industry.

Categories: Drugs, Features, US, FDA, Advertising and Promotion Tags:
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
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