Feature Articles

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

Implementing the New EU Medical Devices Regulations

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: In vitro diagnostics, Medical Devices, Features, Europe, EC Tags: MDR, IVDR
CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation

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: In vitro diagnostics, Medical Devices, Clinical, Submission and registration, Features, Europe, EC Tags: MDR, IVDR, CE Marking
Shaking Palsy, aka Parkinson's Disease, is Still a Mystery

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

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: Active pharmaceutical ingredients, Drugs, Distribution, Manufacturing, Features, US, FDA Tags: Third Party Certification, Import Alert
The Medical Device Coordination Group: a new Authority Under EU Device Regulations

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: In vitro diagnostics, Medical Devices, Features, Europe, EC Tags: MDR, IVDR, Medical Device Coordination Group, MDCG
Eight Key Steps Toward EU-MDR Implementation

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: In vitro diagnostics, Medical Devices, Submission and registration, Features, Europe, EC Tags:
The Life and Times of a Promotional Claims Compendium

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: Drugs, Features, US, FDA, Advertising and Promotion, Communication Tags: Promotional Materials, Promotional Claims, Brand Book
Medical Product Communications Consistent With FDA-Required Labeling Draft Guidance: Navigating the Gray Zone

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: Drugs, Features, US, FDA, Communication Tags: Labeling, Medical Product Communications
New Developments in Payor Communications: Are 20 Years of Uncertainty Over?

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: Drugs, Reimbursement, Features, US, FDA, Communication Tags: Healthcare Economic Information, HCEI, Payor Communications, FDAMA
FDA Enforcement Trends for Broadcast Advertisements

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: Drugs, Features, US, FDA, Advertising and Promotion Tags: Office of Prescription Drug Promotion, OPDP, Warning Letter, YouTube, Social Media
Spain Reimbursement Profile

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Reimbursement, Features, Europe Tags: Spain, AEMPS, Agencia Española de Medicamentos y Productos Sanitarios
Conducting a Successful Advertising and Promotion Review of Restricted Medical Devices

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: Medical Devices, Features, US, FDA, Advertising and Promotion Tags: Product Review Committee, Promotion,
Mistake-Proofing the Workplace

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: Compliance, Manufacturing, Quality, Features Tags: Errors, Defects, Quality
France Reimbursement Profile

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Reimbursement, Features, Europe Tags: ANSM, ACAM, CEESP, CEPS, Reimbursement, France
England Reimbursement Profile

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

Categories: Biologics and biotechnology, Drugs, Reimbursement, Features, Europe, MHRA, NICE Tags: NICE, NHS, Reimbursement
Italy Reimbursement Profile

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Reimbursement, Features, Europe, EMA Tags: AIFA, Agenzia Italiana del Farmaco, Reimbursement
FDA Draft Guidance for Medical Product Communications

This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling. It emphasizes the need for regulatory professionals to better understand and adhere to FDA's evidentiary standards by utilizing examples of the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing and Communications, enforcement actions that should be considered when interpreting what is "consistent with labeling."

Categories: Labeling, Features, FDA, Communication Tags: Communication, Labeling
Preparing for Market: Reimbursement Strategies for Cell and Gene Therapies

In this interview with Regulatory Focus, Ted Slocomb and Michael Werner, two leaders from the Alliance for Regenerative Medicine (ARM), provide insight into future challenges and opportunities for ensuring market access and value-based reimbursement for gene and cell therapies.

Categories: Biologics and biotechnology, Human cell and tissue, Reimbursement, Features, US, FDA Tags: Regenerative Medicine, ARM, Michael Werner, Ted Slocomb
Drug Reimbursement in Canada

This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place.

Categories: Biologics and biotechnology, Drugs, Reimbursement, Features, Canada, Health Canada Tags: Reimbursement, Coverage, Health Technology Assessment, HTA, Common Drug Review
Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes

This article discusses how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement.

Categories: Medical Devices, Features, FDA Tags: Wearables, Mobile Health, mHealth, Patient Reported Outcomes
The Value of Health Technology Assessment Scientific Advice

In recent years, particularly in Europe, a paradigm shift in the regulatory and Health Technology Assessment (HTA) environment has led to an increase in multi-stakeholder acceptance of integrated scientific advice. This article discusses how using integrated scientific advice can support companies in optimizing their product development programs and generate evidence relevant to regulators, HTA bodies and payers.

Categories: Biologics and biotechnology, Drugs, Features, US, Canada, Europe, FDA, EMA, NICE Tags: Health Technology Assessment, HTA
Medical Technology: Connecting Reimbursement and Regulatory for US Medical Devices

This article discusses some basic US reimbursement concepts in the context of the regulatory function and the interplay of the two within the broader business strategy.

Categories: Medical Devices, Reimbursement, Features, US, FDA Tags: Reimbursement, Centers for Medicaid & Medicare Services, CMS, Payers, Coverage
Bioequivalence Studies of Solid Oral Dosage Forms Overview

The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.

Categories: Generic drugs, Features, FDA, EMA, Health Canada, MHLW, PMDA, TGA, WHO Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability
Organizational Culture and Memory in Managing Risk in the Medical Device Industry

This article discusses the importance of organizational culture and memory in the medical device industry's risk management practices. The authors cite new data from an academic study and an existing FDA study of medical device industry participants to suggest risk management practices are not often an integral part of a medical device organization's culture although many organizations claim to have a "culture of quality."

Categories: Medical Devices, Business Skills, Features, US, FDA Tags: Risk Management, Organizational Culture
Is Increasing Antibiotic Resistance Driving Bacteriophage Therapy Closer to Being a Reality?

This article reviews the history of bacteriophage discovery, biology, and potential medical uses, and discusses therapeutic pros and cons compared to and potentially replacing antibiotics due to increasing antibiotic resistance. The article also highlights the future of phage therapy and the need for more scientific investigation and clinical trials prior to approval for human use and the possible patenting and regulatory issues impacting bacteriophage development. The US Food and Drug Administration (FDA) recently covered issues related to bacteriophage development during a workshop in July 2017.

Categories: Biologics and biotechnology, Features, FDA Tags: Bacteriophage, Phage, Antimicrobial Resistance
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