Featured Articles

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

What is a Wearable Device? Lifestyle Device vs. Medical Device

This article discusses how to determine when wearable lifestyle devices, referred to as fitness trackers, might be categorized as medical devices. In cases where fitness trackers are used in particular ways, their categorization as a medical device carries with it specific requirements for compliance to regulations. The article provides useful information to regulatory personnel in assessing how much compliance to the Health Insurance Privacy and Portability Act (HIPPA)1 is expected for a wearable lifestyle device or fitness tracker with imbedded software when used for specific purposes. The article also reviews the migration from lifestyle device to medical device and the accompanying regulatory implications, including FDA's 'intended use.' The concept of "intended use" is key in making the distinction between lifestyle device and medical device, as in the case of wearable fitness devices.2, 3

Categories: Medical Devices, Features, US, FDA Tags: Wearables, Fitness tracker, Lifestyle devices
Testing and Implementing a Web-Based, Country Regulatory Information Management System

This informal case study highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform.

Categories: Project management, Regulatory intelligence, Features Tags: Information management, Regulatory information management system
IND Application Fast Facts

This article provides information companies need when filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups.

Categories: Biologics and biotechnology, Drugs, Clinical, Preclinical, Submission and registration, Features, US, FDA Tags: IND, Investigational New Drug Application
Unifying Best Practices for Managing Regulatory Processes: Part 3

This article highlights the biggest challenges of a fragmented Regulatory Information Management (RIM) landscape as seen in the eyes of life sciences leaders who report their struggles in uniting disparate processes, systems and data.

Categories: Business Skills, Project management, Regulatory strategy, Features Tags:
Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World

This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry.

Categories: Biologics and biotechnology, Drugs, News, US, Europe, FDA, EMA, ISO Tags: ISO IDMP, IDMP, Identification of Medicinal Products
Complex Medicinal Products - the Other 'Biosimilar'

This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products.

Categories: Generic drugs, Regulatory strategy, Submission and registration, Features, US, FDA Tags: Non-Biological Complex Drugs, NBCD
International Medical Device Regulatory Update: News and Views From San Jose

Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.

Categories: Medical Devices, Submission and registration, Features, US, Asia, Latin America and Caribbean, FDA, PMDA Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS
Lessons Learned from Biosimilar Drug Development

This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development.

Categories: Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy, Features, US, Europe, FDA, EMA Tags: Biosimilars
Bridging the Gap: Satisfying Payers in an Era of Expedited Regulatory Pathways 

This article discusses the divergent evidentiary requirements of payers and regulators and the strategies companies can employ to help bridge this gap to ensure expedited regulatory approval effectively translates into reimbursement and patient access.

Categories: Biologics and biotechnology, Drugs, Reimbursement, Features, US, Europe, Asia, FDA, EMA, NICE Tags:
Global Developments of Biosimilars

This article was developed from presentations at the 2016 RAPS Regulatory Convergence meeting held in San Jose. The session titled "Biosimilars," was led by Arpita Shah, PharmD, senior manager, regulatory intelligence and policy, Celgene Corporation. Speakers included  Leah Christl, associate director, therapeutic biologics, FDA, CDER, Sabine Haubenreisser, MSc, PhD, EMA liaison official at the FDA and Tara Sanderson, associate director, project manager, CMC regulatory affairs, ERA Consulting.

Categories: Biologics and biotechnology, Features, US, Canada, Europe, Asia, FDA, EMA, Health Canada, PMDA Tags: Biosimilars
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:
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