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    The Drug Regulatory Landscape in the ASEAN Region

    By Abhishek Tongia This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Asian Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical products, regulatory submissions, pharmacopoeia, halal compliance, stability requirements, pharmacovigilance, product labeling, and drug variation information. Introduction The Association of Southeast Asian Nations (ASEAN) has diverse regulatory re...
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    How to Determine Whether to Comment on Regulatory Documents

    By Kimberly Belsky, Emily Huddle and Elizabeth Rosenkrands-Lange This article addresses the question whether to submit comments to health authorities regarding new regulatory documents or proposed changes to existing documents. The authors provide several considerations for making such decisions as well as ways of determining if the submitted comments have been "successful." Introduction When deciding whether it is useful or beneficial for a company to offer comments o...
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    Developing Regulatory Policy: Recollections of H1N1

    This article provides an overview of how regulatory policy is developed at US Food and Drug Administration (FDA) and specifically in FDA's Center for Biologics Evaluation and Research (CBER), using the 2009 H1N1 swine flu event as a "backdrop." The discussion focuses on enacting clear and transparent policies and also protecting both the public welfare and industry's goals. Introduction In May 2009, as a new employee of US Food and Drug Administration's Center for Biolo...
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    Biomarker Data Management in Clinical Trials: a Model for Success Under New FDA Data Exchange Standards

    This article discusses challenges for researchers pursuing biomarker research and collecting speciality laboratory data increasingly used for FDA drug submissions and requiring datasets that meet new regulatory standards. The authors review new technologies for biomarker data management, leveraging technology and subject matter expertise aimed at gaining improved flexibility, efficiency and compliance. Introduction New US Food and Drug Administration (FDA) data exchange...
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    Monitoring, Analyzing and Interpreting Regulatory Trends

    This article discusses ways in which the regulatory intelligence professional can monitor, identify, analyze, interpret and "stay on top" of regulatory trends to best develop regulatory strategies aimed at maintaining the organization's regulatory compliance readiness. Sources to help identify regulatory trends as well as ways to develop skills for trend analysis and interpretation are examined. Introduction One fundamental responsibility of regulatory intelligence and ...
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    Responding to the Challenges of Meeting the New EU Regulations Requirements: Insight from Three Global Regulatory Executives

    This article describes efforts to prepare Cook Medical and its partners for full implementation of European Union Medical Device Regulations in (EU-MDR) in 2020. It is based on interviews with Cook executives Jennifer Kerr, president of Cook Research Incorporated (CRI), April Lavender, senior vice president of regulatory affairs for Cook Medical, and Sinead Quaid, director, global regulatory affairs, at Cook Ireland. Introduction With the European Parliament's final app...
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    Regulatory Challenges for Direct-to-Patient Clinical Trials

    p> On-site clinical trials may present a number of participation obstacles for individuals living at distances from clinical trial sites or for patients with mobility problems. Direct-to-patient clinical trials can be an alternative. This article reviews applicable regulations and analyzes current strategies for conducting direct-to-patient clinical trials using technologies, such as mobile 'apps' and wearables to report data, as well as the potential for sending trial dr...
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    Marketing Exclusivity for Over-the-Counter Switched Products

    This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation. Introduction Prior to the enactment in 1951 of the Durham-Humphrey Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) , a pharmaceutical manufacturer could decide whether to market a product...
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    Overview of the US Rx-to-OTC Switch Process

    This article provides an overview of the US prescription (Rx) to Over-the-Counter (OTC) switch process, including full switch and partial switch, speaks to the importance of self-care for consumers, and discusses potential areas of opportunity for sponsors and/or industry. Introduction Nonprescription products empower consumers to make informed decisions in selecting appropriate Over-the-Counter (OTC) product(s) for their condition. By increasing the number of produ...
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    The Challenges and Strategies for Today's Rx-to-OTC Switch Programs

    This article presents the background, approaches and regulatory considerations for prescription to Over-the-Counter (Rx-to-OTC) switch programs. The US Food and Drug Administration (FDA) has conservative expectations for the studies supporting a switch in terms of methodologies and sample sizes. Because of this, other countries will sometimes give consideration of consumer studies conducted in foreign countries on a case-by-case basis, in place of studies conducted in th...
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    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
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    How to Conduct Data Integrity Investigation Interviews

    Data Integrity findings have become widespread in the industry with agencies requesting companies to undergo extensive interviews with their employees. These interviews are frequently conducted by independent, trained third parties with the goal of understanding how data integrity failures occurred so that actions can be developed to ensure they do not recur in the future. This article discusses the process and techniques for conducting interviews with personnel. Introdu...