Featured Articles

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

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FDA Draft Guidance for Medical Product Communications

This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling.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:
Regulatory Career Progression

This article discusses pathways for a career as a regulatory professional and possible career progression from junior to senior to managerial level. It summarizes the skills required for each level and what it takes to move up the corporate ladder. It also provides the responsibilities expected of a regulatory professional in a senior management position.

Categories: Career Development, Career Search, Features, Business and Leadership Tags: Career Development, Regulatory Profession
FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities

The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).

Categories: Drugs, Compliance, Manufacturing, Features, US, FDA Tags: Oral Solid Dosage, OSD, Inspections
Biological Products and Biosimilars: Global Naming Debate

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: Biologics and biotechnology, Submission and registration, News, US, Canada, Europe, Asia, Oceania, FDA, EMA, Health Canada, PMDA, TGA, WHO Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN
Medicinal Product Registration in Egypt

This article provides an overview of Egypt's New Drug Application (NDA) procedure for imported brand pharmaceutical products, including new chemical entities and biologics. It discusses the various Egyptian Drug Authority (EDA) departments and the required procedures for moving products through registration and into the market.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Submission and registration, Features Tags: EDA, Egyptian Drug Authority
Identification of Medicinal Products (IDMP) Standards Part 4: Technical Approaches to IDMP

This article discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards with regard to generating, collecting and mapping accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market.

Categories: Biologics and biotechnology, Drugs, Features, US, Europe, FDA, EMA, ISO Tags: Identification of Medicinal Products, IDMP
Regulating Pediatric Studies: An EU and US Perspective

This article presents pediatric regulatory activities conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and highlights global harmonization efforts, collaborative discussions and regulations for pediatric clinical trials.

Categories: Biologics and biotechnology, Drugs, Clinical, Features, US, Europe, FDA, EMA Tags:
Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions

This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.

Categories: Drugs, Submission and registration, Features, US, Canada, Europe, Japan, Oceania, FDA, EMA, Health Canada, PMDA, TGA Tags: Quality Certificates, eCTD, GMP
Conditional Approvals for Early Access to New Medications

This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, US, Europe, Japan, FDA, EMA, PMDA, ICH Tags: Conditional approval, Regenerative medicine
Navigating the Medical Device User Fee Act (MDUFA)

This article examines the benefits for both FDA and the medical device industry derived from "user fees" authorized by the passage of the Medical Device User Fee Act (MDUFA 2002) and its subsequent reauthorizations.

Categories: Medical Devices, Submission and registration, Features, US, CDRH Tags: MDUFA, Medical Device User Fee Act, 510(k), PMA, User Fees
ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Categories: Biologics and biotechnology, Drugs, Quality, Features, US, Europe, FDA, ICH Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD
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