Featured Articles

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

Custom Devices: Improving Patient Quality of Life and Clinician Capabilities

This article discusses the definition of a custom device, how a custom device is developed and regulations to be followed to place a custom device on the market. The article also discusses when a compassionate use request may be appropriate.

Categories: Medical Devices, Compliance, Features, US, CDRH Tags: Custom Medical Devices, Custom Device Exemption, FDASIA, Patient-Specific Devices, Compassionate Use
FDA Expanded Access Pathways

This article discusses the various US regulatory pathways for access to investigational drugs and medical devices outside a clinical trial.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Features, US, FDA Tags: Expanded Access
Practices and Preferences of FDA Medical Device Advisory Committee Members

This article describes, based on survey results, how Medical Device Advisory Committee members prepare for meetings and key factors influencing their thinking.

Categories: Medical Devices, Government affairs, Submission and registration, Features, US, CDRH Tags: Medical Device Advisory Committees
FDA Social Media Guidance–Lessons Learned from the Comment Period

This article reviews and summarizes public comments on FDA's two draft social media guidance documents.

Categories: Drugs, Regulatory strategy, Features, US, FDA, Advertising and Promotion, Communication Tags: Social media guidance, Character space limitations, Twitter
Case Study: Regulatory Advertising and Promotion From a Fellow’s Perspective

This article discusses three components of Purdue University’s Regulatory Pharmaceutical Fellowship from a current fellow’s perspective followed by a candid interview.

Categories: Drugs, Business Skills, Features, US, FDA, Advertising and Promotion Tags: drug advertising and promotion, FDA, Purdue University, Johnson & Johnson, Eli Lilly, regulatory pharmaceutical fellowship
Evolution of Advertising and Promotion Review Systems

This article addresses the evolution of review systems used for advertising and promotion materials.

Categories: Features, Advertising and Promotion Tags: Promotion Review Systems, Medical-Legal-Regulatory Review Committee, MLR, Promotional Review Committee, PRC
Prescription Drug Advertising Versus Non-Advertising Promotion in China: Contrasting Regulation

This article discusses the contrasts between regulatory oversight of prescription drug advertising and non-advertising promotion in China.

Categories: Drugs, Due Diligence, Ethics, Features, China, CFDA, Advertising and Promotion Tags: CFDA, China FDA, drug advertising, non-advertising promotion
Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors

This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies.

Categories: Prescription drugs, Compliance, Government affairs, Features, US, FDA, Advertising and Promotion Tags: Office of Prescription Drug Promotion, OPDP, Office of Inspector General, (OIG), Untitled letters, Warning letters
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
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