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    Considerations for Development and Implementation of a Companion Diagnostic

    This article discusses four key topics any pharmaceutical company should consider for development and implementation of a Companion Diagnostic (CDx) for use with oncology drugs or biologics.   Introduction   The drug development process in the US is extremely long and costly. It is critical to get the patient a drug that is going to work for them. Especially in the oncology space, drugs for the most part are extremely toxic to the patient. Therefore, not only is th...
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    Administrative Law Overview

    This article provides an overview of federal administrative processes as they relate to the regulatory professional. The author reviews and emphasizes the importance of understanding the impact of the administrative process on federally regulated industry, with a focus on federal administrative law under the Administrative Procedures Act ( APA ). She reviews the APA impact on federal agencies, particularly on the United States Food and Drug Administration (FDA), wh...
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    FDA Announces new TRG Rapid Inquiry Program

    This article discusses the US Food and Drug Administration’s (FDA’s) Tissue Reference Group (TRG) new Rapid Inquiry Program (TRIP). 1 The author covers how the TRIP program is designed to work and explains elements of its regulatory changes under the Code of Federal Regulations, Title 21 Part 1271: human cells, tissues and cellular and tissue-based products (HCT/Ps). She describes product registration requirements and exceptions and highlights the program’s multiple benef...
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    China’s State Council Publishes Updated “Measures” for the Administration of Human Genetic Resources

    This article summarizes key points of the “Measures” for the Administration of Human Genetic Resources,” published by the Peoples’ Republic of China’s State Council and currently available only in Chinese. The author reviews the first three of six chapters in the new document and the revised and updated “Measures” as applied to defining “human genetic resources” and regulations imposed by China’s Human Genetic Resource Administration for human genetic resource collection a...
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    Professional Development: Benefits of Obtaining Professional Qualifications

    This article discusses the benefits of formal qualifications for a regulatory career and highlights some of the English-language Master’s-level courses offered globally.   Introduction   Many national governments today have policies in place to foster growth of the medical technology and biopharmaceutical industry to contribute to the new knowledge economy. As the industry grows, organizations continue to face increasing pressure to find and retain talented and sui...
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    eCTD Submission Management

    An initial marketing application submission is a major undertaking that requires a large team, numerous tools and a litany of subprocesses to work together in harmony for a successful outcome. Leaving any of this to chance is likely to result in missed timelines and excessive crunch time. With thorough planning, careful execution and the ability to navigate unexpected challenges, the odds of success can be greatly improved. This high-level walkthrough will raise important ...
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    Critical Thinking and Leadership Skills for Regulatory Professionals

    This article presents the opinions of a retired regulatory executive on the various sets of often underemphasized skills required for a successful regulatory professional career. Every person at every level can use them every day.   Introduction   The past few decades has seen an exciting evolution of our profession. Increasingly complex products, corporate structures and regulatory environment have created a demand for highly skilled regulatory leaders. Their role...
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    Changing Global Regulatory Landscape and Strategy for Drug and Device Operations

    Feature articles in July explored regulatory operations for drugs and devices. Topics included FDA and EU differences in cleanroom specifications, EU accelerated pathway programs, and data requirements for biosimilars versus the reference medicine. Other articles covered India’s new drug and clinical trial rules, China’s new guidance on regulatory inspection and analytical testing documentation, and medical device cybersecurity.   Regulatory Operations for Drugs and Dev...
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    Medical Device Cybersecurity Regulatory Pathway

    The snowballing innovation in the medical industry has resulted in a marketplace where it is common for medical devices to be connected to the internet. To keep pace, the US Food and Drug Administration (FDA) is leaning on the learnings from other industries to springboard the medical industry into a stronger cybersecurity position. This article discusses the changes in technology that has brought about the need for cybersecurity, regulatory history, recent developments in...
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    EU Accelerated Pathways

    This article summarizes accelerated pathways for regulatory approval for new drug or biologic development in the European Union (EU), including requirements for conditional marketing authorization, authorization under exceptional circumstances, accelerated assessment and Priority Medicines Scheme (PRIME) in addition to accelerated pathway requirements associated with orphan drug designation.   Introduction   Why pursue special designations and pathways?   The...
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    China NMPA Publishes new Notification on Regulatory Inspection and Analytical Testing Documentation

    The Chinese regulatory system for marketing authorization differs from other regulatory systems, especially with regard to inspection and analytical testing requirements. This article is a translation of the first official notification, providing details on the differences, as well as expected timelines.   Introduction   As part of the Marketing Authorization (MA) procedure for pharmaceutical products in China, the Chinese National Medical Products Administration (...
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    FDA and EU GMP Annex 1 Differences in Cleanroom Specifications

    Based on a presentation at Interphex in April 2019, 1 this article discusses the contradictions between the US and EU requirements for cleanroom Good Manufacturing Practices (GMPs). The author discusses particle concentration for cleanrooms “at rest,” particle contamination in the air, start-up testing vs. routine monitoring, risk analysis and “interlocking” doors. The author concludes that there should be globally harmonized GMP norms for cleanroom operation based on “ha...