Posted 02 December 2016
By Gloria Hall
The following is a summary of feature articles posted throughout November with links and a preview of what's to come in December.
Feature articles in November presented common misconceptions about quality control and quality assurance, the importance of developing a robust quality management system, process validation, the appropriate response time for FDA warning letters, regulations for prescription drug advertising, the impact of the 2016 revision of the ISO 13485 standard on the medical device industry and risk management for suppliers, how to manage regulatory change events and interactions with health authorities, the evolution of Paediatric Legislation (PL) in the European Union, and a review of Regulatory Convergence Hot Topics from 2016.
Start-up organizations have a unique opportunity to create and implement robust compliance and quality system paradigms and systems "right the first time" to accommodate growth and prevent later compliance issues. In his article, You Only Get One Chance to Make a First Impression—Do It Right The First Time (DIRTFT), Chellson explores methods for developing a regulatory-compliant Quality Management System (QMS) and why it is so important.
While the regulatory industry focuses on quality, it can be an unknown as to how regulatory professionals can measure the quality of the outputs generated from that department. In DiMarco's article,The Measure of Quality, sheaddresses common misconceptions about quality control and quality assurance, what it means to measure quality, and why it is important in our regulated industry.
Godshalk explains process validation in a fun way using pie baking as an analogy in his article Process Validation Review: How Many Ways Can You Bake a Pie? He discusses the importance of providing scientific evidence to demonstrate the production of consistent quality batches of Drug Substance (DS) or Drug Product (DP) once process controls are in place, including process inputs and variables, design space and quality control.
Warning letters issued in 2016 by the US FDA were reviewed by Minsk and Nduom in their article Why Respond to an FDA 483 in a Timely Manner. Two companies had received a FDA 483 List of Observations following an inspection and 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. Their article explores the question did the company have too much time on its hands?
Murray covers the 2016 revision of the ISO 13485 standard and its impact on risk management for suppliers in his article How Will ISO 13485:2016 Impact Your Relationship With Suppliers? He explores the possible implications for the medical device industry and how the standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships.
Government, Regulatory Bodies, Law and Legislation
While the regulations for prescription drug advertising are clearly codified in 21 CFR 202, the interpretation and application of these regulations continue to evolve to address the technological advancements and modern mediums utilized in promotion. In their article, Recent Trends in Prescription Drug Promotion Enforcement, Nguyen and Vechery summarize the 2016 enforcement letters and analyze how different data cuts, groupings and correlations to relatable events can be constructed to explain different trends. They also introduce some key events along the enforcement letter timeline.
Almost 10 years ago, new Paediatric Legislation (PL) came into force that reshaped the regulatory landscape for pediatrics medicines in Europe to improve the health of children in the European Union (EU). In his article, A Summary of 10 Years of Paediatric Legislation in the European Union, Van Bronswijk discusses the evolution of the regulation and how the law was designed to facilitate the development and availability of medicines for children from birth to less than 18 years, ensure medicines for use in children are of high quality, ethically researched and authorized appropriately and improve the availability of information on the use of medicines for children without subjecting children to unnecessary trials or delaying the authorization of medicinal products in adults.
Research and Technology
In the second of a three-part series, Reilly provides responses to an independent study designed to identify the primary challenges and best practices when managing regulatory change events and interactions with health authorities. In his article, Automation Best Practices for Managing Regulatory Processes: Part 2, he shares observations from regulatory experts on how to compliantly and efficiently manage change events, such as label or manufacturing changes, with health authorities globally.
RAPS 2016 Review: Regulatory Convergence Hot Topics
Bobbit provides a summary of hot topics presented at this year's RAPS 2016 Regulatory Convergence and includes a high level recap of innovation and technology, Zika, real world evidence, faster patient access to innovative and critical medicine, recent developments in off-label promotion and medical devices.
Feature Articles to Look for in December
December's collection of feature articles will focus on biosimilars with authors discussing global developments, challenges, legal issues, lessons learned from biosimilar drug development, and complex medicinal products—the other biosimilar. Other features will highlight wearable devices: lifestyle device vs. medical device and strategies to ensure expedited regulatory pathways. December also will highlight the third in the RIM series on best practices for managing automated regulatory processes. Look for these feature articles and other hot topics throughout December.