Featured Articles

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

CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions

To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and changes; and inspection case analysis through observations by various international regulatory authorities.

Categories: Government affairs, Regulatory intelligence, Features, China, FDA, CFDA, WHO Tags: Chinese Center of Food and Drug Inspection, CFDI
CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development

This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.

Categories: Prescription drugs, Generic drugs, Clinical, Compliance, Features, China, CFDA Tags: Draft Guidance
Where to Find Publicly Disclosed Regulatory Precedent in the EU, US and Canada

This article provides a better understanding of the types of information available from regulatory authorities by outlining sources of precedent focused on development activities, regulatory submission and evaluation, and approval and post-authorization activities.

Categories: Biologics and biotechnology, Drugs, Clinical, Labeling, Regulatory strategy, Submission and registration, Features, US, Europe, FDA, EMA Tags:
Small Organizations, Big Regulatory Strategy

This article discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses also can learn from their innovative approaches. These include navigating incentives, understanding and utilizing technology tools for regulatory intelligence like social media and crowdsourcing, and embracing a team mentality to build agile and efficient regulatory programs with a strong underlying alignment with business development.

Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, US, Europe, Asia, FDA, EMA Tags: Regulatory Strategy, SMEs
Regulatory Intelligence - an Integrated Tool to Strengthen Drug Development Projects and Regulatory Strategies

This article discusses the role of regulatory intelligence in drug development as well as the functional and personal competencies desired for a regulatory intelligence professional to succeed in providing value to the research and development organization.

Categories: Regulatory strategy, Regulatory intelligence, Features, FDA, EMA Tags: Regulatory Intelligence
Strategies for Smarter Compliance in a Technology-Driven FDA Environment

The article provides an overview of the significance of technology in the regulatory compliance process and offers strategies for smarter compliance.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Submission and registration, Features, US, FDA Tags: eCTD, Electronic Common Technical Document
Regulatory Intelligence - Delivering Regionally, Operating Globally

This article discusses the impact of the Internet with regard to the amount and transparency of information offered by regulatory health agencies with an emphasis on the role of regulatory intelligence in monitoring the global environment and the subsequent communication obtained from this information.

Categories: Drugs, Regulatory intelligence, Features, FDA, EMA, ICH Tags:
Aging Revisited: an Amazing Continuous Process

This article will briefly discuss the definition of aging, what it means to age, the process itself, why we age and anti-aging methods designed to increase longevity. Active research has indicated a number of medications have increased the life span in mice and other laboratory animals. Duplicating the results in human patients could make anti-aging medications the next category of truly miracle drugs.

Categories: Biologics and biotechnology, Drugs, Ethics, Features Tags:
What is a Wearable Device? Lifestyle Device vs. Medical Device

This article discusses how to determine when wearable lifestyle devices, referred to as fitness trackers, might be categorized as medical devices. In cases where fitness trackers are used in particular ways, their categorization as a medical device carries with it specific requirements for compliance to regulations. The article provides useful information to regulatory personnel in assessing how much compliance to the Health Insurance Privacy and Portability Act (HIPPA)1 is expected for a wearable lifestyle device or fitness tracker with imbedded software when used for specific purposes. The article also reviews the migration from lifestyle device to medical device and the accompanying regulatory implications, including FDA's 'intended use.' The concept of "intended use" is key in making the distinction between lifestyle device and medical device, as in the case of wearable fitness devices.2, 3

Categories: Medical Devices, Features, US, FDA Tags: Wearables, Fitness tracker, Lifestyle devices
Testing and Implementing a Web-Based, Country Regulatory Information Management System

This informal case study highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform.

Categories: Project management, Regulatory intelligence, Features Tags: Information management, Regulatory information management system
IND Application Fast Facts

This article provides information companies need when filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups.

Categories: Biologics and biotechnology, Drugs, Clinical, Preclinical, Submission and registration, Features, US, FDA Tags: IND, Investigational New Drug Application
Unifying Best Practices for Managing Regulatory Processes: Part 3

This article highlights the biggest challenges of a fragmented Regulatory Information Management (RIM) landscape as seen in the eyes of life sciences leaders who report their struggles in uniting disparate processes, systems and data.

Categories: Business Skills, Project management, Regulatory strategy, Features Tags:
Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World

This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry.

Categories: Biologics and biotechnology, Drugs, News, US, Europe, FDA, EMA, ISO Tags: ISO IDMP, IDMP, Identification of Medicinal Products
Complex Medicinal Products - the Other 'Biosimilar'

This article discusses Non-Biological Complex Drugs (NBCDs) and how FDA and other regulatory agencies review and approve generic forms of these products.

Categories: Generic drugs, Regulatory strategy, Submission and registration, Features, US, FDA Tags: Non-Biological Complex Drugs, NBCD
International Medical Device Regulatory Update: News and Views From San Jose

Several sessions at the 2016 RAPS Regulatory Convergence, held in San Jose, California in September, focused on medical device regulations and regulatory changes worldwide. These included: FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.

Categories: Medical Devices, Submission and registration, Features, US, Asia, Latin America and Caribbean, FDA, PMDA Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS
Lessons Learned from Biosimilar Drug Development

This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development.

Categories: Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy, Features, US, Europe, FDA, EMA Tags: Biosimilars
Bridging the Gap: Satisfying Payers in an Era of Expedited Regulatory Pathways 

This article discusses the divergent evidentiary requirements of payers and regulators and the strategies companies can employ to help bridge this gap to ensure expedited regulatory approval effectively translates into reimbursement and patient access.

Categories: Biologics and biotechnology, Drugs, Reimbursement, Features, US, Europe, Asia, FDA, EMA, NICE Tags:
Global Developments of Biosimilars

This article was developed from presentations at the 2016 RAPS Regulatory Convergence meeting held in San Jose. The session titled "Biosimilars," was led by Arpita Shah, PharmD, senior manager, regulatory intelligence and policy, Celgene Corporation. Speakers included  Leah Christl, associate director, therapeutic biologics, FDA, CDER, Sabine Haubenreisser, MSc, PhD, EMA liaison official at the FDA and Tara Sanderson, associate director, project manager, CMC regulatory affairs, ERA Consulting.

Categories: Biologics and biotechnology, Features, US, Canada, Europe, Asia, FDA, EMA, Health Canada, PMDA Tags: Biosimilars
Insulin: The First Truly Miracle Drug

This article will discuss diabetes, the process of the discovery of insulin and provide brief biographies of two intrepid people involved.

Categories: Biologics and biotechnology, Research and development, Features, Canada Tags: Diabetes, Insulin, Drug Discovery
The Measure of Quality

This article details how regulatory professionals can measure the quality of the outputs generated from the quality department. Additionally, the terms Quality Assurance (QA), Quality Control (QC) and quality management are often erroneously used interchangeably. Included are details about how these terms differ.

Categories: Quality, Features Tags: Quality assurance, Quality control, Quality management
A Summary of 10 Years of Paediatric Legislation in the European Union

This article summarizes 10 years of experience with paediatric regulations in the EU.

Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, Features, Europe, EMA, EC Tags: Paediatric Legislation, Paediatric Investigation Plan, Paediatric Committee, (PDCO)
Automation Best Practices for Managing Regulatory Processes: Part 2

This article shares observations from regulatory experts on how to compliantly and efficiently manage change events, such as label or manufacturing changes, with health authorities globally.

Categories: News, Communication Tags:
How Will ISO 13485:2016 Impact Your Relationship With Suppliers?

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Categories: Medical Devices, Manufacturing, Features, ISO Tags: ISO 13485:2016, Quality Management System
Why Respond to an FDA 483 in a Timely Manner

We reviewed some warning letters issued by the US Food and Drug Administration (FDA) this year that reminded us of the 1981 hit song by Styx, "Too Much Time on My Hands." Two companies had received a FDA 483 List of Observations following an inspection.1, 2 The companies accordingly responded to the agency within 15 business days; however, they also provided subsequent substantive responses to the FDA 483 outside of the 15-day window. In the warning letters, FDA acknowledged the companies' initial responses, but noted the subsequent responses were untimely and not reviewed by the agency as it considered potential next enforcement steps.

Categories: Compliance, Regulatory strategy, Features, US, FDA, Communication Tags:
Recent Trends in Prescription Drug Promotion Enforcement

This article presents brief summaries of the 2016 enforcement letters, analyzes how different data cuts, groupings and correlations to relatable events can be constructed to explain different trends and introduces some key events along the enforcement letter timeline.

Categories: Features, US, FDA, Advertising and Promotion, Communication Tags:
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