Search Results for

Filtering on: "content types features"

Showing 1 – 25  of 351

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

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

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

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

Guest Editorial: Does Nutrition Have a Role in Disease Management? By Barbara O. Schneeman, PhD - Published 13 October 2017

This editorial is meant to encourage discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases.

Categories: Features, FDA

Tags: Nutrition, Disease Management, Dietary Reference Intakes, Medical Foods

Overcoming Distinctive Regulatory Barriers for the Development of Medical Foods By Josy Giordano-Schaefer, PhD, Manfred Ruthsatz, PhD, Heinrich Schneider, MD - Published 09 October 2017

This article compares the legal definitions of drugs and medical food and outlines the distinctive regulatory hurdles for medical food, in particular, the need for substantiating distinctive nutritional requirements. The authors also make recommendations on how those regulatory hurdles could be overcome with definitive regulatory guidance for both distinctive nutritional requirements (DNR) and modification of normal diet alone (MODA).

Categories: Features, US, FDA

Tags: Medical Food

Canada Reimbursement Profile By Matthew Brougham, MSc, William O'Neil, PhD, Dima Samaha, MAS, PharmD - Published 04 October 2017

This profile summarizes reimbursement processes in Canada, presents information for key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Canada, Health Canada, Drugs, Medical Devices, Reimbursement

Tags: CADTH, Health Canada, INESSS, pCPA, PMPRB

Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods By Gloria Hall - Published 04 October 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in October.

Categories: Features, Canada, Europe, US, FDA, Health Canada, MHRA, NICE, Advertising and Promotion, Labeling, Nutritional and dietary supplements, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

Germany Reimbursement Profile By Elvira Müller, PhD, MPH - Published 03 October 2017

This profile summarizes the reimbursement process in Germany, presents responsibilities for key stakeholders and highlights issues for consideration early in the development process.

Categories: Features, Europe, Drugs, Medical Devices, Reimbursement, Submission and registration

Tags: G-BA, IQWiG, GKV-SV, InEK

New Developments in Payor Communications: Are 20 Years of Uncertainty Over? By Glenn Byrd, MBA, RAC - Published 29 September 2017

This article discusses the state of FDA guidance relating to the US Food and Drug Administration Modernization Act (FDAMA-114), particularly in the area of Healthcare Economic Information (HCEI), and looks at the questions requiring clarification in order for industry to be able to effectively change how economic and other clinical information is communicated to payors and similar groups. The author also evaluates elements of FDA's 2017 Draft Guidance.

Categories: Features, US, FDA, Communication, Drugs, Reimbursement

Tags: Healthcare Economic Information, HCEI, Payor Communications, FDAMA

FDA Enforcement Trends for Broadcast Advertisements By Justin Mann, Julie Tibbets - Published 28 September 2017

This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information.

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

Tags: Office of Prescription Drug Promotion, OPDP, Warning Letter, YouTube, Social Media

Spain Reimbursement Profile By Jesús Cuervo, PhD, Carlos Crespo, MBA, MHE, PhD, Jenifer Ehreth, MHA, PhD - Published 27 September 2017

This profile summarizes the reimbursement process in Spain, presents key stakeholders and highlights what should be considered early in the development process.

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

Tags: Spain, AEMPS, Agencia Española de Medicamentos y Productos Sanitarios

Conducting a Successful Advertising and Promotion Review of Restricted Medical Devices By Lynn Deutsch - Published 25 September 2017

This article provides insight for regulatory professionals regarding developing a successful advertising and promotional review of restricted medical devices. It demonstrates how medical device manufacturers and pharmaceutical companies can improve communication and collaboration between regulatory and marketing to streamline and improve the compliance review process for promotional materials and achieve an effective marketing strategy.

Categories: Features, US, FDA, Advertising and Promotion, Medical Devices

Tags: Product Review Committee, Promotion,

Mistake-Proofing the Workplace By Zachary Sherman, Max Sherman - Published 22 September 2017

This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors.

Categories: Features, Compliance, Manufacturing, Quality

Tags: Errors, Defects, Quality

France Reimbursement Profile By Jenifer Ehreth, MHA, PhD - Published 20 September 2017

This profile summarizes the reimbursement process, presents key stakeholders in France and highlights complexities to be considered early in the development process.

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

Tags: ANSM, ACAM, CEESP, CEPS, Reimbursement, France