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Filtering on: "content types features"

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What is a Wearable Device? Lifestyle Device vs. Medical Device By Meredith May, MS, RAC, Anna C. McFadden, PhD - Published 17 January 2017

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: Features, US, FDA, Medical Devices

Tags: Wearables, Fitness tracker, Lifestyle devices

Testing and Implementing a Web-Based, Country Regulatory Information Management System By Elizabeth Rehfeld - Published 13 January 2017

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: Features, Project management, Regulatory intelligence

Tags: Information management, Regulatory information management system

IND Application Fast Facts By Valerie Fauvelle - Published 06 January 2017

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: Features, US, FDA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Submission and registration

Tags: IND, Investigational New Drug Application

Biosimilar Drug Development, Complex Medicinal Products, Medical Device Regulations, Research and Technology and a Preview of January By Gloria Hall - Published 04 January 2017

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

Categories: Features, Biologics and biotechnology, Drugs, Medical Devices

Unifying Best Practices for Managing Regulatory Processes: Part 3 By Jim Reilly - Published 21 December 2016

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: Features, Business Skills, Project management, Regulatory strategy

Complex Medicinal Products - the Other 'Biosimilar' By Douglas W. Balogh, PhD - Published 21 December 2016

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

Categories: Features, US, FDA, Generic drugs, Regulatory strategy, Submission and registration

Tags: Non-Biological Complex Drugs, NBCD

International Medical Device Regulatory Update: News and Views From San Jose By Randolph Fillmore - Published 20 December 2016

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: Features, Asia, Latin America and Caribbean, US, FDA, PMDA, Medical Devices, Submission and registration

Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS

Lessons Learned from Biosimilar Drug Development By Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD - Published 19 December 2016

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: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars

Bridging the Gap: Satisfying Payers in an Era of Expedited Regulatory Pathways  By Richard Macaulay, PhD - Published 16 December 2016

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: Features, Asia, Europe, US, EMA, FDA, NICE, Biologics and biotechnology, Drugs, Reimbursement

Global Developments of Biosimilars By Randolph Fillmore - Published 15 December 2016

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

Tags: Biosimilars

Insulin: The First Truly Miracle Drug By Max Sherman - Published 08 December 2016

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

Categories: Features, Canada, Biologics and biotechnology, Research and development

Tags: Diabetes, Insulin, Drug Discovery

Quality and Compliance, Regulatory Research, Policy Issues and a Preview of December By Gloria Hall - Published 02 December 2016

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

Categories: Features, Compliance, Quality

Tags: Regulatory Focus, Feature Articles, Feature Summary

The Measure of Quality By Jennifer DiMarco - Published 29 November 2016

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: Features, Quality

Tags: Quality assurance, Quality control, Quality management

A Summary of 10 Years of Paediatric Legislation in the European Union By Hans van Bronswijk, MD, PhD - Published 28 November 2016

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

Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: Paediatric Legislation, Paediatric Investigation Plan, Paediatric Committee, (PDCO)

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

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

Categories: Features, ISO, Manufacturing, Medical Devices

Tags: ISO 13485:2016, Quality Management System

Why Respond to an FDA 483 in a Timely Manner By Alan Minsk, Kelley Nduom - Published 21 November 2016

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: Features, US, FDA, Communication, Compliance, Regulatory strategy

Recent Trends in Prescription Drug Promotion Enforcement By Francis Nguyen, Colin Vechery - Published 17 November 2016

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

The Evolving Role of the Regulatory Professional By Pallavi Trivedi MPH, RAC, Sharad Trivedi, MS, PMP - Published 28 October 2016

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: Features, Business Skills

A Regulatory Experience of a Lifetime By Peter J. Isikwe - Published 26 October 2016

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

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

FDA Issues Notices of Violation for Promoting Investigational Products as Safe and Effective By Alan Minsk, Kelley Nduom - Published 20 October 2016

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: Features, US, FDA, Advertising and Promotion, Communication, Drugs

Tags: Notice of Violation

Global Regulatory Submissions: How to Build a Plan That Works Everywhere, Every Time By Paul Bridges - Published 18 October 2016

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: Features, EMA, FDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Standardization Best Practices for Managing Regulatory Processes: Part 1 By James Reilly - Published 11 October 2016

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: Features, Communication, Regulatory strategy

Tags: Standardization, Data Capture, Processes

Global Regulatory Strategy By Prerna Menon - Published 11 October 2016

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: Features, Japan, Canada, Europe, US, EMA, FDA, Health Canada, MHLW, PMDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Priority Review, Accelerated Approval, Breakthrough Designation, Fast Track Designation, Conditional Approval, PRIME, Adaptive Licensing, Accelerated Assessment, Sakigake

Changing Times of Advertising and Promotion, Hot Topics and a Preview of October By Gloria Hall - Published 06 October 2016

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

Do Recent First Amendment Court Developments Deal a Blow to the Government? By Alan Minsk, Kelley Nduom - Published 05 October 2016

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: Features, US, FDA, Advertising and Promotion, Communication, Drugs, Government affairs

Tags: Amarin, Pacira, Vascular Solutions, First Amendment, Off-label promotion