Featured Articles

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

PMDA Consultation in Japan

This article focuses on PMDA consultations for drug development.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Features, Japan, PMDA Tags: PMDA, Japan PMDA, Regulatory Meetings in Japan
A Lifecycle Approach to ANDA Filings: Lessons Learned

This article discusses the benefits of implementing a lifecycle approach to ANDA filings to avoid refuse-to-receive notices and deficiencies, ensuring readiness for preapproval inspections.

Categories: Generic drugs, Compliance, Submission and registration, Features, US, CDER Tags: ANDA, RTR, Refuse to Receive, GDUFA, Generic Drug Deficiencies
Evolution of Board Responsibility for Compliance Program Oversight

This article examines how OIG's expectations of the role played by a company's Board of Directors in overseeing corporate compliance programs have changed over time in a manner corresponding to Audit Committee requirements of Sarbanes-Oxley.

Categories: Compliance, Features, US Tags: OIG, CIA, Corporate Integrity Agreement
Health Canada to Regulate Reprocessors of Single Use Medical Devices as Manufacturers

This article explains reasons for reprocessing Single Use Devices (SUDs), major concerns about this practice and the potential impact of these new requirements.

Categories: Medical Devices, Manufacturing, Features, Canada, Health Canada Tags: MEDEX, SUD, Single-Use Devices, Reprocessing
What Life Sciences Companies Need to Know About the Foreign Corrupt Practices Act

An overview of the Foreign Corrupt Practices Act (FCPA) and practical and effective compliance strategies for life sciences companies.

Categories: Compliance, Ethics, Features, US Tags: FCPA, Foreign Corrupt Practices Act
Agency Meetings with the US Food and Drug Administration

This article outlines various types of meetings supported by FDA and provides common best practices for holding successful meetings.

Categories: Regulatory strategy, Features, US, FDA Tags: FDA Meeting, Type A Meeting, Type B Meeting, Type C Meeting, Meeting With FDA
The Untold Compliance Story Behind Sunshine Data

This article discusses some challenges presenting accurate and complete data in compliance with transparency reporting requirements, while weighing in on reports against public misperception of the data. It also provides manufacturers with reporting methods to ensure greater data accuracy, while preserving the integrity of physician interactions.

Categories: Ethics, News, US, Advertising and Promotion Tags: FMV, Fair Market Value, Sunshine Act, Transparency
Regulatory Quality Compliance Programs for Drugs and Biologics in the US and Canada

An overview of compliance activities applicable for drugs and biologics in the US and Canada, as well as useful tools to strengthen quality compliance programs.

Categories: Drugs, Compliance, Manufacturing, Packaging, Quality, Features, US, Canada, FDA, Health Canada Tags:
The Southeast Asian Regulatory Environment for Pharmaceuticals: Part 2

This article, the second in a two-part series on the Southeast Asian regulatory environment for pharmaceuticals, examines the regulatory landscape in Brunei, Vietnam, Laos, Myanmar (Burma) and Cambodia. Part one, published in December 2014, examined the larger ASEAN markets of Singapore, Malaysia, Indonesia, the Philippines and Thailand.

Categories: Drugs, Regulatory strategy, Submission and registration, Features, Asean Tags: ASEAN, Southeast Asia, Brunei, Vietnam, Laos, Myanmar, Cambodia
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:
« 1 2 3 4 5  ... »