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Filtering on: "content types features"

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CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions By Yingying Liu, Siegfried Schmitt - Published 15 February 2017

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: Features, China, CFDA, FDA, WHO, Government affairs, Regulatory intelligence

Tags: Chinese Center of Food and Drug Inspection, CFDI

Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February By Gloria Hall - Published 06 February 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in February.

Categories: Features, China, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, Biologics and biotechnology, Compliance, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles, Feature Summary

CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development By Yingying Liu, Siegfried Schmitt - Published 06 February 2017

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: Features, China, CFDA, Clinical, Compliance, Generic drugs, Prescription drugs

Tags: Draft Guidance

Where to Find Publicly Disclosed Regulatory Precedent in the EU, US and Canada By Linda Bowen, MS, RAC, João Duarte, MPharm - Published 01 February 2017

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: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Labeling, Regulatory strategy, Submission and registration

Small Organizations, Big Regulatory Strategy By Angela Johnson, MSE, PMP, RAC - Published 30 January 2017

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: Features, Asia, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Regulatory Strategy, SMEs

Regulatory Intelligence - an Integrated Tool to Strengthen Drug Development Projects and Regulatory Strategies By João Duarte, MPharm, Anne Vinther Morant, PhD, MSc - Published 27 January 2017

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: Features, EMA, FDA, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Intelligence

Strategies for Smarter Compliance in a Technology-Driven FDA Environment By Matthew M. Lowe - Published 26 January 2017

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

Categories: Features, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Submission and registration

Tags: eCTD, Electronic Common Technical Document

Regulatory Intelligence - Delivering Regionally, Operating Globally By Emily Huddle, BSc, Soufiane Dib, PharmD, Marie Claire Aquilina, MPharm, MSc - Published 25 January 2017

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: Features, EMA, FDA, ICH, Drugs, Regulatory intelligence

Aging Revisited: an Amazing Continuous Process By Max Sherman - Published 24 January 2017

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: Features, Biologics and biotechnology, Drugs, Ethics

What is a Wearable Device? Lifestyle Device vs. Medical Device By Meredith May, MS, RAC, Anna C. McFadden, PhD - Published 17 January 2017

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: Features, US, FDA, Medical Devices

Tags: Wearables, Fitness tracker, Lifestyle devices

Testing and Implementing a Web-Based, Country Regulatory Information Management System By Elizabeth Rehfeld - Published 13 January 2017

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: Features, Project management, Regulatory intelligence

Tags: Information management, Regulatory information management system

IND Application Fast Facts By Valerie Fauvelle - Published 06 January 2017

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: Features, US, FDA, Biologics and biotechnology, Clinical, Drugs, Preclinical, Submission and registration

Tags: IND, Investigational New Drug Application

Biosimilar Drug Development, Complex Medicinal Products, Medical Device Regulations, Research and Technology and a Preview of January By Gloria Hall - Published 04 January 2017

The following is a summary of feature articles posted throughout December with links and a preview of what's to come in January.

Categories: Features, Biologics and biotechnology, Drugs, Medical Devices

Unifying Best Practices for Managing Regulatory Processes: Part 3 By Jim Reilly - Published 21 December 2016

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: Features, Business Skills, Project management, Regulatory strategy

Complex Medicinal Products - the Other 'Biosimilar' By Douglas W. Balogh, PhD - Published 21 December 2016

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

Categories: Features, US, FDA, Generic drugs, Regulatory strategy, Submission and registration

Tags: Non-Biological Complex Drugs, NBCD

International Medical Device Regulatory Update: News and Views From San Jose By Randolph Fillmore - Published 20 December 2016

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: Features, Asia, Latin America and Caribbean, US, FDA, PMDA, Medical Devices, Submission and registration

Tags: National Evaluation System for Medical Devices, NEST, Precision Medicine, COFEPRIS

Lessons Learned from Biosimilar Drug Development By Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD - Published 19 December 2016

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: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars

Bridging the Gap: Satisfying Payers in an Era of Expedited Regulatory Pathways  By Richard Macaulay, PhD - Published 16 December 2016

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: Features, Asia, Europe, US, EMA, FDA, NICE, Biologics and biotechnology, Drugs, Reimbursement

Global Developments of Biosimilars By Randolph Fillmore - Published 15 December 2016

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: Features, Asia, Canada, Europe, US, EMA, FDA, Health Canada, PMDA, Biologics and biotechnology

Tags: Biosimilars

Insulin: The First Truly Miracle Drug By Max Sherman - Published 08 December 2016

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

Categories: Features, Canada, Biologics and biotechnology, Research and development

Tags: Diabetes, Insulin, Drug Discovery

Quality and Compliance, Regulatory Research, Policy Issues and a Preview of December By Gloria Hall - Published 02 December 2016

The following is a summary of feature articles posted throughout November with links and a preview of what's to come in December.

Categories: Features, Compliance, Quality

Tags: Regulatory Focus, Feature Articles, Feature Summary

The Measure of Quality By Jennifer DiMarco - Published 29 November 2016

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: Features, Quality

Tags: Quality assurance, Quality control, Quality management

A Summary of 10 Years of Paediatric Legislation in the European Union By Hans van Bronswijk, MD, PhD - Published 28 November 2016

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

Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: Paediatric Legislation, Paediatric Investigation Plan, Paediatric Committee, (PDCO)

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

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

Categories: Features, ISO, Manufacturing, Medical Devices

Tags: ISO 13485:2016, Quality Management System

Why Respond to an FDA 483 in a Timely Manner By Alan Minsk, Kelley Nduom - Published 21 November 2016

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: Features, US, FDA, Communication, Compliance, Regulatory strategy