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Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda

of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from;

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International Regulatory Harmonization Amid Globalization of Drug Development

the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development;

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Advancing Regulatory Science for Medical Countermeasure Development

countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure;

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Large Simple Trials and Knowledge Generation in a Learning Health System

practicality of knowledge generation for medical decision making and medical product development; considers the concepts of LST design, examples;

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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and;

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Stronger Food and Drug Regulatory Systems Abroad

, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and;

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Personalized Medicine & the FDA's Emerging Role

Over the past few years, a number of products that signal a new era of medical product development have entered the market or come on the;

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Regulating the Crypto Economy

orders in the crypto economy and native payment systems that do not rely on conventional institutions for value transfer. A regulatory blueprint;

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Antibody Therapeutics

postgraduate and medical students with an authoritative overview of the field.;

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Examining the Impact of Real-World Evidence on Medical Product Development

in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series;

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Medical Product Regulatory Affairs

regulatory affairs in all major global markets for pharmaceuticals and medical devices. Following a look at drug development, complete sections are;

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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food;

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Innovation and Growth in the Global Economy

research by forward-looking, profit-seeking agents. Traditional growth theory emphasizes the incentives for capital accumulation rather than;

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Handbook of Medical Device Regulatory Affairs in Asia

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put;

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An International Perspective on Advancing Technologies and Strategies for Managing Dual-Use Risks

Biotechnology Development 4 Emerging and Converging Technologies 5 Models for Managing Change Appendix A: Workshop Agenda Appendix B: Participant;

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Nano-Pharmacokinetics and Theranostics

important sub discipline of nanoscience and medical sciences because of the increasing safety issues of nanosystems on living organisms. This book;

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Fundamental Neuropathology for Pathologists and Toxicologists

of neuropathology including chemical and environmental, biological, medical, and regulatory details important for performing an analysis of toxicant-induced;

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Pharmaceutical Product Development

pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians;

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Hydrophilic Polymer Coatings for Medical Devices

and devices. It concisely provides both the scientific basics of this class of polymers and the up-to-date information needed for product;

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Hydrophilic Polymer Coatings for Medical Devices

and devices. It concisely provides both the scientific basics of this class of polymers and the up-to-date information needed for product;

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Product Liability and Innovation

lawsuits chill new product development. Product Liability and Innovation provides an overview and an engineering perspective on the product;

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How to Integrate Quality by Efficient Design (QbED) in Product Development

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges;

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Inhaled Pharmaceutical Product Development Perspectives

consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory;

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Medical Licensing and Discipline in America

by physicians as a condition for license renewal and the Federation's policy development work advocating for both initiatives among all state;

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Medical Licensing and Discipline in America

by physicians as a condition for license renewal and the Federation's policy development work advocating for both initiatives among all state;

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Plastics in Medical Devices

on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability;

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Human Development and Global Institutions

fill critical gaps across borders and entire regions. A positive, forward-looking agenda for the future of global governance would have to;

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