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
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Tags: Office of Prescription Drug Promotion, FDA, draft guidance, social media, drug ads on social media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.
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
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
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
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