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
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