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.
By Gloria Hall
Over the past several weeks, feature articles presented the critical role of regulatory strategy and intelligence in the drug development process, sources for global regulatory precedent, information requirements for an investigational new drug application, benefits of a global web-based information management system, the regulatory implications of FDA's intended use for medical devices and the significance of technology in regulatory compliance. Other features summarized four draft guidances newly released by China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs and a study on aging with some interesting findings in regard to the next generation of miracle drugs.
Regulatory Intelligence (RI) has been defined as a way of managing available evidence by screening, analyzing and communicating information to support optimal outcomes in regulatory activities. These activities tend to be mostly regulatory strategies linked to regulatory paths to approval, lifecycle management and procedural hurdles.In their article, "Regulatory Intelligence—an Integrated Tool to Strengthen Drug Development Projects and Regulatory Strategies," Duarte and Morant discuss 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.
Analyzing regulatory precedent and locating regulatory "evidence" are essential activities for a biopharmaceutical regulatory intelligence department and helpful in predicting regulatory outcomes. Bowen's article, "Where to Find Publicly Disclosed Regulatory Precedent in the EU, US and Canada," provides the types of information available from regulatory authorities and outlines sources of precedent focused on development activities, regulatory submission and evaluation and approval and post-authorization activities.
In her article, "IND Application Fast Facts," Fauvelle discusses how to make the Investigational New Drug Application (IND) application process more efficient when filing with FDA. She answers common questions and addresses concerns that develop across multiple companies and multidisciplinary groups. Over the past two decades, the Internet has led to an unprecedented volume of readily accessible and seemingly endless information. The enormous capacity of the Internet created the push for increased transparency and access to public availability of information. In recent years, regulatory health agencies have responded with the availability of more information via transparency and public communication initiatives. In Huddle's article,"Regulatory Intelligence—Delivering Regionally, Operating Globally," the author addresses 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.
An informal case study, "Testing and Implementing a Web-Based, Country Regulatory Information Management System," by Rehfeld highlights the benefits of having structured, reliable information on country regulatory requirements by leveraging the content from a web-based platform.
Medical Devices and Regulatory Strategy
Ten or 15 years ago, the concept of a wearable medical device would probably bring to mind a diabetic insulin pump or a cochlear implant. Today, wearable lifestyle and medical devices are becoming more available to the average and generally healthy person. In May and McFadden's article, "What is a Wearable Device? Lifestyle Device vs. Medical Device," the authors discuss how to determine when wearable lifestyle devices, referred to as fitness trackers, might be categorized as medical devices. They provide useful information to regulatory personnel in assessing how much compliance to the Health Insurance Privacy and Portability Act (HIPPA) is expected for a wearable lifestyle device or fitness tracker with imbedded software when used for specific purposes. The authors also review the migration from lifestyle device to medical device and the accompanying regulatory implications, including FDA's 'intended use.'
In May 2017, FDA will no longer accept submissions of drug applications that do not follow the electronic Common Technical Document (eCTD) format. In his article, "Strategies for Smarter Compliance in a Technology-Driven FDA Environment," Lowe addresses this key milestone in the modernization of compliance in the life science industry and provides an overview of the significance of technology in the regulatory compliance process. He also offers strategies for smarter compliance.
Recently,president Trump said that "competition is the key to lower drug prices," and he promised to "oppose anything that makes it harder for smaller, younger drug companies to take the risk" of bringing a medication to market."1 In Johnson's article "Small Organizations, Big Regulatory Strategy," the author discusses how small and young organizations, including start-ups, build powerful regulatory strategy programs that complement their research and business development efforts. Established businesses can learn from some of the innovative approaches discussed including 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.
Law and Legislation
In "CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development," Liu and Schmitt summarize four draft guidances published by the China Food and Drug Administration (CFDA) in December regarding on-site inspection of generic drugs, including how CFDA will evaluate their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.
Science and Research
Sherman presents a brief definition of aging, what it means to age, the process itself, why we age and anti-aging methods designed to increase longevity in his article "Aging Revisited—an Amazing Continuous Process." 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 antiaging medications the next category of truly miracle drugs.
Feature Articles to Look for in February
February's collection of feature articles will include an update on some helpful regulatory intelligence tools for drugs and present a RI tool compendium with a comprehensive list of tools available organized by functional area.Other topics will include regulation and oversight of gene therapy in the US, the changing regulatory landscape of Advanced Therapy Medicinal Products (ATMPs), the Chinese Center of Food and Drug Inspection's (CFDI's) new global drug inspection trend study, part two of the IDMP standards series on the global impact of the standards and implementation guidance and new indications for use including a description of the immune function of crocodiles, the search for new antibiotics, antimicrobial peptides and future research for anti-cancer agents.
Look for these feature articles and other hot topics throughout February.
- Mangan, D. "Trump Vows to get Drug Prices Lower, Tells Drugmakers he Wants Them to Manufacture in the US." Biotech and Pharmaceuticals. CNBC website. http://www.cnbc.com/2017/01/31/trump-tells-drugmakers-he-wants-them-to-manufacture-in-the-us.html. Accessed 31 January 2017.