Featured Articles

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

Practical Guidance for Regulatory Professionals on Combination Products

This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities.

Categories: Combination products, Research and development, Submission and registration, Features, US, Europe, FDA, EMA, EC, ICH, IMDRF Tags: Combination products, Design validation, Risk management, IMDRF
510(k) Submissions: Current Trends and Tips

This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process.

Categories: Medical Devices, Regulatory strategy, Submission and registration, Features, US, CDRH Tags: 510(k), Sterilization validation, deficiencies, guidance
The 'Catch-Up' 510(k) - A Submission Often Overlooked

This article discusses "catch-up" 510(k) submissions, circumstances under which a "catch-up" 510(k) submission should be considered, content and timing of such a submission and procedural recommendations for this submission type.

Categories: Medical Devices, Submission and registration, Features, US, CDRH Tags: 510(k), catch-up 510(k),
FDA Regulation and Personalized Medicine

This article discusses examples of personalized medicine in industry as well as examples of FDA regulatory activities with respect to personalized medicine.

Categories: Biologics and biotechnology, Clinical, Labeling, Postmarket surveillance, Research and development, Regulatory strategy, Submission and registration, Features, US, FDA Tags: Personalized Medicine
Registration Procedures for Medicinal Products in China

This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs.

Categories: Drugs, Compliance, Government affairs, Submission and registration, Features, China, CFDA Tags: Center for Drug Evaluation, Chinese Pharmacopoeia Commission, National Institutes for Food and Drug Control, Center for Certification of Drugs, Center for Drug Re-Evaluation, CDE, CPC, NIFDC, CCD, CDR, Marketing Authorization,
Pharmaceutical Marketing via Social Media

This article discusses the ongoing effort by the pharmaceutical industry to use social media as a marketing tool. It presents benefits and limitations of using this form of media and describes recent progress in public communication.

Categories: Drugs, Features, US, FDA, Advertising and Promotion, Communication Tags: Social Media, IMS Health Social Media Engagement Index
Draft National Medical Device Policy—2015: A Review and Analysis

This article reviews the Draft National Medical Device Policy (NMDP-2015) proposed by the government of India and evaluates potential pros and cons of its most important feature.

Categories: Medical Devices, Government affairs, Manufacturing, Research and development, Features, India Tags: Draft National Medical Device Policy, NMDP-2015, Make in India
Creating Type IA and Type IB Variation Submissions in Europe

This article discusses the creation of minor variations within the European Union.

Categories: Biologics and biotechnology, Drugs, Submission and registration, Features, Europe, EMA Tags: Type IA Variations, Type IB Variations
Regulatory Information or Regulatory Intelligence? What About ROI?

The following commentary explores the responsibilities of consultants and clients to achieve an effective partnership.

Categories: Business Skills, Regulatory intelligence, Features Tags:
Post-Marketing Plans: An Often Overlooked Component of FDA Advisory Committee Meeting Discussions

The article analyzes the proportion of FDA Advisory Committees specifically asked to discuss or vote on issues related to post-approval safety activities.

Categories: Postmarket surveillance, Features, US, FDA, Communication Tags: Post-marketing Plans, Advisory Committee Meetings
A Brighter Future for Regulatory Professionals

Regulatory Focus (RF) Interviews Bird Shi, Regional Regulatory Affairs Director, Abbott Nutrition, Greater China.

Categories: Nutritional and dietary supplements, Government affairs, Features, Asia, CFDA Tags: Abbott, Food regulations
What's in a Name? Nonproprietary Naming of Biological Products

This article discusses recently published FDA draft guidance on Nonproprietary Naming of Biological Products.

Categories: Biologics and biotechnology, Labeling, Regulatory strategy, News, US, CBER Tags: Biological naming, Biosimilar naming, INN, International Nonproprietary Name
The Four Cs of Regulatory Professional's Use of Webinars

This article discusses the potential applications of webinars as an appropriate tool for use by regulatory professionals in the workplace.

Categories: Career Development, Features Tags: Webinars, Education, Professional Development
US Preparedness for Public Health Emergencies: Medical Countermeasures and Emergency Use Authorization

This article discusses how medical products needed during public health emergencies can be made available to the public through the use of FDA's Emergency Use Authorization (EUA).

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory strategy, Features, US, FDA Tags: Emergency Use Authorization, EUA, Public Health Emergencies, CBRN,
Preparing for an FDA Advisory Committee Approval Meeting

This article discusses the nuances of FDA Advisory Committee approval meetings and provides an interpretive overview of what regulatory professionals need to know to prepare for a meeting.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Regulatory strategy, Submission and registration, News, US, CBER, CDER, CDRH, Business and Leadership, Communication Tags: Advisory Committee Meetings, AdComm,
Advancing Regulatory Science: Research Success in a Public-Private Partnership

This article discusses how a public-private partnership brought stakeholders together to advance regulatory science research in patient preference assessment.

Categories: Medical Devices, Business Skills, Government affairs, Research and development, Regulatory strategy, Features, US, CDRH, Communication Tags: Medical Device Innovation Consortium, MDIC, Patient Centered Benefit-Risk, (PCBR)
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
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