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),
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
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
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
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
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
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