Featured Articles

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

Magnetic Resonance Safety Testing and Labeling for Devices

This article reviews testing and labeling expectations FDA is likely to require, supporting “MR Safe” or “MR Conditional” labeling for passive, implanted medical devices.

Categories: Medical Devices, Labeling, Features, US, CDRH Tags: MRI, MRI Testing, Magnetic Resonance Imaging, MR Safe, MR Conditional
Scientific Advice Meetings With Health Canada

How does one go about meeting with Health Canada about scientific issues, and how can regulatory professionals best prepare for this meeting? This article explains the meeting process, the rationale behind meeting with the regulator, and what materials regulatory professionals need to have at the ready.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, News, Canada, Health Canada Tags: Scientific Meeting
What Influences CDER Advisory Committee Members?

Over the past two decades, the US Food and Drug Administration’s (FDA’s) Center for Drug and Evaluation and Research (CDER) has been developing new, expedited pathways to help bring innovative medical products to market more efficiently. These pathways include fast track designation, accelerated approval, priority review and, more recently, breakthrough therapy. Through these expedited pathways, some products have been approved with fewer clinical data than traditionally are required.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Features, US, CDER Tags: CDER Advisory Committee, Advisory Committee, FDA Advisory Committee, CDER Advisory Panel, Influence
Six Recommendations Regarding Upcoming UDI Compliance Dates

This article provides an overview of the medical device industry’s challenges in the next phase of UDI implementation, including a review of the latest best practices for I/LS/LS and Class II device labelers.

Categories: Medical Devices, Labeling, Features, US, CDRH Tags: UDI, Unique Device Identification, GUDID, Device Identifier, Packaging
The Importance of Business Acumen to the Regulatory Profession

Two Becton Dickinson (BD) executives, Chairman, CEO and President Vince Forlenza and Senior Vice President, Regulatory Affairs, Rick Naples, share their thoughts on driving performance by developing savvy regulatory professionals who understand the importance of international regulatory strategy.

Categories: Medical Devices, Business Skills, Features Tags: Vince Forlenza, Rick Naples, Becton Dickinson
China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

A review of the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014, providing insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China.

Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, Features, China Tags: China, CFDA, China Food and Drug Administration, clinical trials, new drug approvals, new biologics approvals, Chinese patients, international multicenter trials, IMCT, Asia Pacific
Leveraging Expedited Programs for Drugs and Biologics for Serious Conditions and Rare Diseases

An analysis of the impact of FDA’s four expedited programs on development and review of drugs for serious conditions over the last two-and-a-half years since breakthrough therapy designation was introduced, including a performance summary.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, US, FDA Tags: Breakthrough therapy designation, fast track designation, priority review, accelerated approval pathway, unmet medical needs
FDA’s Expedited Programs for Serious Conditions: An Overview

An overview of FDA’s four expedited drug development programs for serious or life-threatening conditions: fast track designation, breakthrough therapy designation, priority review designation and the accelerated approval pathway.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, US, FDA Tags: Fast track designation, breakthrough therapy, priority review, accelerated approval, serious conditions, life-threatening conditions
Melanoma Treatments: A History of US FDA Approvals

Studying the history of regulatory approvals can provide insights into regulator expectations for new products. Data sets on which US Food and Drug Administration (FDA) approvals for melanoma treatment products were based were examined to determine whether trends have changed in the level of evidence provided.

Categories: Biologics and biotechnology, Drugs, Clinical, Labeling, Postmarket surveillance, Research and development, Features, US, FDA Tags: Melanoma, cancer, malignancies, malignant melanoma, approval history, US FDA approvals
Insights on Japan's 'Sakigake' Regulatory Strategy

A review of Japan’s “Sakigake” (“pioneer”) regulatory strategy, designed to bolster innovation in the biopharmaceutical industry.

Categories: Drugs, Regulatory strategy, Features, Japan Tags:
Expedited Medical Device Submissions in the US: Special 510(k), Abbreviated 510(k), HDE

An overview of expedited pathways for US medical devices that are alternatives to Traditional 510(k)s and Premarket Approval Applications (PMAs). These include Special 510(k), Abbreviated 510(k) and Humanitarian Device Exemption (HDE) submission types.

Categories: Medical Devices, Submission and registration, Features, US, FDA Tags: expedited pathways, Traditional 510(k)s, Special 510(k)s, Abbreviated 510(k)s, Humanitarian Device Exemption, HDE, clearance
Teaching: An Integral Responsibility for Regulatory Professionals

Effective teachers make a significant difference in student achievement. Online courses are no substitute. Interaction with a trainer allows ideas to be exchanged freely and without communication barriers. Qualified teachers help learners make fewer mistakes and, thus, reduce the likelihood of errors in the workplace. Tips on class preparation, presentation, assessment and follow-up for regulatory professionals who must all, at some point, be teachers.

Categories: Features, Business and Leadership, Communication Tags:
Posting Public Comments Can Increase Consumer Engagement with FDA

An argument that timely online posting by the US Food and Drug Administration of all public comments submitted by individual consumers would increase public engagement and align well with other efforts by the agency to facilitate public input about policy issues.

Categories: Features, US, FDA, Communication Tags:
CROs: Selecting and Managing Contract Regulatory Development Resources

CROs have emerged as critical partners in drug development, whether they offer comprehensive or focused services. This partnership requires effective integration of internal and external processes and programs that are managed proactively.

Categories: Drugs, Project management, Features Tags:
Out of Africa: Six Regulatory Articles that Span the Continent

Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southern Africa, West Africa, Central Africa, Northern Africa and South Africa. The articles contain the regulatory agency contacts/responsible parties for countries in each geographic area. The collection also includes an articles on RCOREs.

Categories: Drugs, Government affairs, Project management, Submission and registration, Features, Africa Tags: Africa, South Africa, Northern Africa, North Africa, West Africa, Central Africa, East Africa, Southern Africa, RCOREs, regional centres of excellence, submission, submission and registration, dossier, regulatory submission, regulatory training, regulatory strategy, WHO, NEPAD, East African Community, EAC, regulatory challenges, harmonization, ministry of health, ministere de la sante
Outsourcing Pharmacovigilance in Small Pharmaceutical Companies: A Perspective

A look at the blended approach and other options for an outsourced pharmacovigilance model and their benefits for small pharmaceutical companies. This article provides advice on the steps required to complete a successful PV outsourcing project.

Categories: Drugs, Project management, Features Tags:
Outsourcing: Not My Problem?

The vast majority of outsourcing decisions affect regulatory submissions/applications and pharmacovigilance to varying degrees. Therefore, outsourcing should be of considerable interest to regulatory professionals. By making outsourcing issues their concern, regulatory professionals can ensure it is not a problem.

Categories: Drugs, Project management, Regulatory strategy, Features Tags:
Pharmaceutical Outsourcing: A Korean Perspective

Background on the South Korean pharmaceutical industry and how companies select and choose suppliers and contractors, including regulatory affairs or regulatory compliance consultants or providers.

Categories: Drugs, Regulatory strategy, Features, Korea Tags:
Regulatory Focus Recap: January 2015

A recap of Regulatory Focus feature articles published in January 2015 for your reading convenience.

Categories: Drugs, In vitro diagnostics, Medical writing, Preclinical, Features Tags:
South Africa Medicines Regulatory System Overview

South Africa’s pharmaceutical regulating body, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals. In the last decade, limited resources have meant increased review timelines. To ensure a timely and successful application, it is crucial for pharmaceutical companies to facilitate open discussions and exchange information with key MCC regulators, listed herein.

Categories: Drugs, Government affairs, Submission and registration, Features, Africa Tags: South Africa, Medicines Control Council, responsible pharmacist, harmonization initiative, CTD, dossier
Writing Skills for the Regulatory Professional

Later this year, RAPS will publish a new book, Regulatory Writing, co-authored and edited by Mukesh Kumar, PhD. This article is an introductory overview of his upcoming book and demonstrates that strong writing skills are a core competency of regulatory professionals.

Categories: Medical writing, Project management, Features, Communication Tags: writing skills, technical writing, writing training
'Cafeteria-Style' Approach to Training for the Regulatory Technical Writer

A flexible training methodology, referred to as the "cafeteria-style" approach, provides effective, efficient instruction for onboarding regulatory technical writers. This style of training is also useful in providing ongoing professional development for current staff.

Categories: Medical writing, Project management, Features, Communication Tags: regulatory writing, training, regulatory technical writers, training buckets
Writing Regulatory Documents with E-Submissions in Mind

Preparing regulatory documents for electronic submission (known as publishing) can be time consuming and complicated. This article offers some practical tips to help authors prepare regulatory documents in a more efficient manner, which can shorten submission timelines and save resources.

Categories: Medical writing, Project management, Submission and registration, Features Tags: electronic submissions, cross-referencing, hyperlinks, eCTD, templates, style guides, leaf titles
Types of In Vitro Diagnostics: Clearing Up the Confusion

In vitro diagnostics: It is easy to get lost in a seemingly foreign language of acronyms for IVDs—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? An overview of the various types of IVDs.

Categories: In vitro diagnostics, Features, US, FDA Tags: FDA, in vitro medical devices, IVDs, FDA guidance, GPRs, CLIA
Integrated Summaries of Effectiveness and Safety: Writing in the Context of the CTD

Two common approaches to writing Integrated Summaries of Effectiveness and Safety (ISE and ISS, respectively) and the Summaries of Clinical Efficacy and Safety are discussed, with the focus based on medical writers’ experience with document preparation for a US NDA or BLA. However, given that the Common Technical Document (CTD) format is accepted in the US, the EU and Japan, the same strategies also can be applied to those regions.

Categories: Biologics and biotechnology, Drugs, Medical writing, Submission and registration, Features, US, FDA Tags:
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