Featured Articles

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

Stories From the Promotional Review Battlefront

This article shares advertising and promotion experiences and presents strategies to improve a team's performance.

Categories: Features, FDA, Business and Leadership, Advertising and Promotion, Communication Tags: Advertising and Promotion, Promotional Review Committee, PRC
Social Media: Changing the Rules for Regulatory Professionals

This article discusses social media's role in the changing regulatory landscape and how regulatory professionals must evolve to ensure compliance with FDA requirements specific to the medical device field.

Categories: Drugs, Medical Devices, Regulatory strategy, Features, US, FDA, Advertising and Promotion Tags: Social media, Facebook, Twitter, LinkedIn
Do Public Hearing Participants Influence Outcomes of FDA Advisory Committee Meetings?

This article discusses the importance of the open public hearing portion of an FDA Advisory Committee meeting.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Submission and registration, Features, US, FDA Tags: Advisory Committee Meetings, Open Public Hearing,
The Evolving Approach of Presenting Risk Information to Consumers

This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency.

Categories: Drugs, Medical Devices, Compliance, Government affairs, Features, US, FDA, Advertising and Promotion Tags: Office of Prescription Drug Promotion, FDA, draft guidance, social media, drug ads on social media
Celebrity Endorsements—Lights, Camera, Enforcement Action?

This article discusses the use of celebrity endorsements to promote a disease state or a pharmaceutical drug.  

Categories: Drugs, Due Diligence, Ethics, Regulatory strategy, Regulatory intelligence, Features, US, FDA, Advertising and Promotion Tags: Kim Kardashian, OPDP, warning letter, drug advertising, DTCA, Samuel L. Jackson
Quality Characteristics From a Regulatory Perspective

This article presents information, terminology and references addressing violations from inspections conducted by FDA investigators or Notified Bodies.

Categories: Tags: quality characteristics, FDA, quality metrics, FDA guidance
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
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