Featured Articles

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

Intractable Epilepsy and the Value of Formulated Ketogenic Diet Products

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?

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

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

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

Categories: Drugs, Medical Devices, Reimbursement, Features, Canada, Health Canada Tags: CADTH, Health Canada, INESSS, pCPA, PMPRB
Germany Reimbursement Profile

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

Categories: Drugs, Medical Devices, Reimbursement, Submission and registration, Features, Europe Tags: G-BA, IQWiG, GKV-SV, InEK
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
Resources and Training for Regulatory Professionals

This article discusses the knowledge path for regulatory professionals from a career's early stages through specialization. It recommends a variety of ways to keep current on evolving regulatory issues, including on-the-job training, self-education via the Internet, attending conferences, networking, and membership in professional organizations.

Categories: Career Development, Regulatory intelligence, Features, Business and Leadership Tags:
Pharmaceutical Cleaning Processes

This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification.

Categories: Drugs, Features, FDA, WHO Tags: Cleaning, Washing, Rinsing, Cleaning Validation
Ten Secrets to Regulatory Success

This article highlights "10 secrets to success" for regulatory professionals that may not be taught in formal regulatory affairs training programs, but practices the author learned "on the job." It includes suggestions for developing regulatory submissions and the importance of good writing, doing your "homework" and systematizing work procedures.

Categories: Career Development, Features, Communication Tags:
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