Featured Articles

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

Bringing Structure to Substance Information

This article discusses compliance challenges  pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured  substance information.

Categories: Active pharmaceutical ingredients, Postmarket surveillance, Articles, Features, ISO, APIs Tags: pharmaceuticals, pharmacovigilance, International Organization for Standardization, ISO, Identification of Medicinal Products, IDMP
Competency Expectations for the Regulatory Professional: A Changing Paradigm

This article discusses the impact of recent industry developments and pharmaceutical market trends on the expertise and experience required for today's regulatory professionals.

Categories: Career Development, Articles, Features, About the Profession Tags: competency, regulatory competency, regulatory profession, professional development
Managing Pharmacovigilance in Digital Health Initiatives

This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives.

Categories: Prescription drugs, Postmarket surveillance, Articles, Features, US, FDA Tags: pharmacovigilance, pharmaceutical, adverse events, adverse event reporting, digital health
ISO IDMP - Putting the Pieces Together for Investigational Data

This  article reviews the European Medicines Agency (EMA) Master Data Management Roadmap (MDM), the role of the European Union Drug Regulating Authorities Clinical Trials database (EudraCT) and the European Union (EU) portal in regard to investigational  product information.

Categories: Research and development, Articles, Features, Europe, EMA, ISO Tags: investigational data, clinical trials, pharmaceuticals, ISO, International Organization for Standardization, IDMP, Identification of Medicinal Products
Pioneer's Innovative 18th Century Dental Devices Widely Relevant Today

This article discusses the work of Pierre Fauchard—an 18th century surgeon who specialized in the development of dental devices while meticulously documenting his work. Many dental devices on the market today have roots in Fauchard’s work.

Categories: Medical Devices, Medical writing, Articles, Features Tags: Fauchard, dental, dentistry, dental devices
Ebola—Expedited Pathways for Drugs and Vaccines in Europe: The EMA Perspective

This article discusses the European Medicines Agency (EMA) facilitated expedited pathways for drug and vaccine approval to enable  fast access to market to fight emerging diseases, such as Ebola.

Categories: Prescription drugs, Articles, Features, Europe, Africa, EMA Tags: Ebola, vaccine, vaccines, European Medicines Agency, EMA
Harmonization Creates Opportunities for Both Regulatory Professionals and Agencies in Developing Countries

This article  discusses how the regulatory profession in  developing countries can benefit from global regulatory harmonization.

Categories: Articles, Features, India, Middle East, FDA, MHRA, TGA, ICH Tags: harmonization, developing countries
DSHEA: Preserving Legal Access to Chinese Herbal Medicine or Researching new Remedies for Malaria and Other Tropical Diseases

This article explores the  importance of continued access by researchers to Chinese medicinal herbs via  DSHEA, in light of a potential increase in tropical diseases in historically  non-tropical regions.

Categories: Nutritional and dietary supplements, Articles, Features, US, FDA Tags: DSHEA, malaria, tropical dseases, Chinese medicine, herbal medicine
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
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