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Filtering on: "content types features"

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The Challenges and Strategies for Today's Rx-to-OTC Switch Programs By Julie Aker, MT(ASCP) - Published 13 December 2017

This article presents the background, approaches and regulatory considerations for prescription to Over-the-Counter (Rx-to-OTC) switch programs. The US Food and Drug Administration (FDA) has conservative expectations for the studies supporting a switch in terms of methodologies and sample sizes. Because of this, other countries will sometimes give consideration of consumer studies conducted in foreign countries on a case-by-case basis, in place of studies conducted in the local country.

Categories: Features, US, FDA, Over the counter drugs, Prescription drugs

Tags: OTC, OTC Switch

Resolving Gene Editing Technology's Ethical and Regulatory Challenges By Vidya Narayanaswami, PhD, Dr. Stephen F. Amato - Published 13 December 2017

This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges.

Categories: Features, FDA, Biologics and biotechnology, Ethics

Tags: Gene Editing, Gene Therapy, CRISPR, Cas9

How to Conduct Data Integrity Investigation Interviews By David W. Husman, PhD, CPGP, RAC, Wanda Eng - Published 13 December 2017

Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel.

Categories: Features

Preparing for and Managing FDA Inspections By Sharry Arora, Bhaskar Saxena - Published 13 December 2017

The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish.

Categories: Features, US, FDA, Compliance, Drugs, Manufacturing

Tags: Inspections, GxP, Quality Management System, QMS, CAPA, CMC, Validation, Form 483, Quality Assurance

Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation By Yvonne Middlefell, FRAPS, RAC - Published 12 December 2017

This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use.

Categories: Features, Europe, EC, In vitro diagnostics, Labeling, Medical Devices, Submission and registration

Tags: IVDR, Annex 1, Risk Management

A New Regulatory Paradigm for Medical Devices in India By Dushyant Kumar, MPharm, RAC, Vibhu Yadav, MPharm, Nancy Mathewson, Esq - Published 12 December 2017

This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.

Categories: Features, India, GHTF, IMDRF, ISO, Medical Devices

Tags: Draft Medical Device Rules 2017, GHTF, Bureau of Indian Standards, BIS

Successful Human Factors Programs: Key Considerations from a Regulator's Perspective By Melissa R. Lemke - Published 12 December 2017

This article provides two regulatory leaders insight on human factors engineering considerations for helping manufacturers optimize user interfaces and successfully meet regulatory expectations to bring safe, effective and usable medical devices to market. It was developed from an interview with Shannon Hoste, team lead of the Center for Devices and Radiological Health's (CDRH's) human factors premarket evaluation team and Michael Ryan, acting deputy director in the division of anesthesiology, general hospital, respiratory, infection control, and dental devices.

Categories: Features, US, FDA, Medical Devices, Research and development

Tags: Human Factors Engineering, HFE, Guidance

CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation By Jonathan Bray, PhD, Michelle O'Connor, PhD, Robert D. Cumming - Published 01 December 2017

This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system.1 The regulations, intended to affect greater IVD safety and reliability, expand the definition of an IVD to include software used as any part of an IVD, as well as an IVD used for providing information concerning the predisposition to a medical condition or disease. An IVD also may be a device used to predict a treatment response or reaction to a treatment. Moving forward, all Class B through Class D IVDs will require some level of conformity assessment by an independent Notified Body.

Categories: Features, Europe, EC, Clinical, In vitro diagnostics, Medical Devices, Submission and registration

Tags: MDR, IVDR, CE Marking

Implementing the New EU Medical Devices Regulations By Randolph Fillmore - Published 01 December 2017

This article discusses the steps toward implementing the new EU regulations on medical devices with a focus on better pre-market control, establishing oversight and data systems. It is based on a presentation given by Salvatore Scalzo at the RAPS EU Regulatory Essentials Workshop held in Brussels, Belgium in July 2017.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices


Shaking Palsy, aka Parkinson's Disease, is Still a Mystery By Max Sherman - Published 24 November 2017

This article discusses disease etiology, history and symptoms of Parkinson's disease as well as ongoing research and new treatment options.

Categories: Features

Tags: Parkinson's Disease

Third Party Certification for Drugs Associated With an Import Alert Exception By Allyn R. Becker, PhD, Mark Lookabaugh - Published 24 November 2017

The US Food and Drug Administration (FDA) has begun a widely recognized campaign of intensified surveillance of foreign manufacturers of Active Pharmaceutical Ingredients (APIs) and finished drug products. Failure to comply with the regulatory requirements for good manufacturing practice can subject a foreign firm to an import alert, thereby cutting off access to commercial distribution in the US. This article provides an overview of the consequences of an import alert and the steps that may be required to have an alert lifted by FDA.

Categories: Features, US, FDA, Active pharmaceutical ingredients, Distribution, Drugs, Manufacturing

Tags: Third Party Certification, Import Alert

The Medical Device Coordination Group: a new Authority Under EU Device Regulations By Robert D. Cumming, Nancy W. Mathewson, Esq. - Published 14 November 2017

This article discusses the organization and functions of the Medical Device Coordination Group (MDCG) established under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The article explains how both groups will be important players in the conformity assessment body 'notification' process and in determining how notified bodies assess and certify devices and in serving as a reviewing body for making regulatory and jurisdictional decisions for the European Commission.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR, Medical Device Coordination Group, MDCG

Eight Key Steps Toward EU-MDR Implementation By Gert Bos - Published 13 November 2017

This article offers eight steps toward ensuring compliance with the new European Union Medical Device Regulations. It is based on the author's presentation given in July 2017 on "EU Regulatory Essentials, Medical Device, and In Vitro Diagnostics: Transitioning From Current Directives to new Regulations" at the RAPS Brussels Conference.1, 2

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration

Nutrition, Health and Disease Management, Advertising, Promotion, Labeling and a Preview of November's MDR, IVDR Update By Gloria Hall - Published 07 November 2017

Feature articles over the past several weeks covered two main themes: nutrition, health and disease management and advertising, promotion, labeling.

Categories: Features, Advertising and Promotion, Labeling, Nutritional and dietary supplements

Tags: Regulatory Focus, Feature Articles, Editorial

Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward By Kathleen D'Hondt, Yolanda Sanz, Manfred Ruthsatz - Published 06 November 2017

This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and drugs to support innovation to benefit society, while guaranteeing safety and efficacy of products and ensuring the science base.

Categories: Features, Europe, US, EC, FDA, Nutritional and dietary supplements

Tags: Microbiome, Diet, Medical Food, Health Claims

Surveillance of Adverse Events for Dietary Supplements By Rick Kingston, PharmD - Published 03 November 2017

This article discusses past and present congressional legislation and FDA regulations pertaining to reporting dietary supplement adverse events. It also focuses on the value of post-market surveillance to protect consumers and defines and clarifies the regulatory professional's role in communicating product safety as technology continues to expand data access.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Dietary Supplements, Adverse Events

The Supplement OWL: the Dietary Supplement Industry's Hallmark Self-Regulatory Initiative By Andrea Wong, PhD - Published 01 November 2017

This article discusses the role industry self-regulation plays in fostering trust from regulators, lawmakers, and consumers. It introduces an important self-regulatory initiative for the dietary supplement industry - the Supplement Online Wellness Library (OWL) - laying out its history and how it will serve regulatory audiences, retailers, and ultimately, consumers.

Categories: Features, Nutritional and dietary supplements

Tags: Dietary Supplements

FSMA and its Impact on Dietary Supplement Companies By Gisele Atkinson, Nicki Jacobs - Published 31 October 2017

This article discusses FSMA-related regulations and stresses the impact the regulations will have on the dietary supplement industry.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Dietary Supplements, FSMA, Food

The US Regulatory Environment for Probiotics in Food By Andrea Wong, PhD - Published 31 October 2017

This article discusses the US Food and Drug Administration's (FDA's) revised draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, and its potential impact on the regulatory status of probiotic ingredients. It outlines the opportunities for probiotics as medical foods, as well as the potential regulatory challenges associated with this category. The author encourages probiotics manufacturing companies to engage in 'self-regulatory initiatives.'

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Probiotics, Food

NDI Guidance: The Waiting Game By Jennifer M. Adams, JD, Ashish R. Talati, JD, MS, RAC - Published 30 October 2017

This article discusses FDA's publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) and the implications regarding the lack of finalization in the year following its publication. The authors make suggestions regarding what companies may begin doing prior to and in anticipation of eventual finalization.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: New Dietary Ingredient Notifications, NDI

The Life and Times of a Promotional Claims Compendium By Rebecca Rivera Torres, MS, RD, CSSD - Published 30 October 2017

This article discusses developing a "promotional claims compendium" to review pharmaceutical marketing materials. It highlights the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization.

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

Tags: Promotional Materials, Promotional Claims, Brand Book

Preparing for Dietary Supplement Label Changes Under the Final Rule for Nutrition and Supplements Facts Labels By Jesús Muñiz, MS - Published 27 October 2017

This article summarizes several key provisions introduced by FDA's new Nutrition and Supplement Facts Labels rule with a specific focus on their effect on the development and marketing of dietary supplements. Potential implications of the new requirements and changes are presented and suggestions are provided for managing various aspects of the new rule.

Categories: Features, US, FDA, Labeling, Nutritional and dietary supplements

Tags: Dietary Supplements, Labeling, Label Changes, Supplements Fact Label

Medical Product Communications Consistent With FDA-Required Labeling Draft Guidance: Navigating the Gray Zone By Nikki Foeller - Published 25 October 2017

This article discusses the changing landscape for promotional review regarding the shift in evidentiary standards introduced in the 2017 Consistent with the Label Draft Guidance. It also highlights industry perspectives for consideration to companies looking to apply the principles outlined in the Draft Guidance or in preview to what could be addressed in a future revision.

Categories: Features, US, FDA, Communication, Drugs

Tags: Labeling, Medical Product Communications

Innovating Patient Driven Nutritional Care Across Europe: The Optimal Nutritional Care for All (ONCA) Multi-Stakeholder Initiative By Frank de Man, LLM, PhD, Cees Smit, Drhc, Manfred Ruthsatz, PhD, RAC, FRAPS - Published 24 October 2017

This article addresses a European public-private healthcare initiative to implement Optimal Nutrition Care for All (ONCA) for patients. It underlines the importance of an effective multi-stakeholder approach in 16 participating countries, based on sound policymaking. A fit-for-purpose, innovation-friendly regulatory framework is required to help provide appropriate, timely, and cost-efficient healthcare solutions for increased patient access.

Categories: Features, Europe

Intractable Epilepsy and the Value of Formulated Ketogenic Diet Products By Eric Kossoff, MD - Published 18 October 2017

This article discusses the benefits of the Ketogenic Diet (KD) and the Modified Atkins Diet (MAD) for adults and children as treatments for intractable epilepsy. It offers a patient-oriented interpretation of regulatory requirements for medical foods as well as study data demonstrating KD efficacy. The article was based on a presentation given at the 2017 RAPS Convergence, during the medical food session on Modification of Diet Alone (MODA) vs. access and convenience matters.

Categories: Features, FDA

Tags: Ketogenic Diet, Medical Food