The Combination Products Handbook

The Combination Products Handbook
Title The Combination Products Handbook PDF eBook
Author Susan Neadle
Publisher CRC Press
Pages 439
Release 2023-05-16
Genre Medical
ISBN 1000874583

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Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
Title A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition PDF eBook
Author Stephen M. Kanovsky
Publisher
Pages 672
Release 2020-09
Genre Drugs
ISBN 9781935065876

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FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

The Combination Products Handbook

The Combination Products Handbook
Title The Combination Products Handbook PDF eBook
Author Susan W. Neadle
Publisher
Pages 0
Release 2023
Genre
ISBN 9781032291635

Download The Combination Products Handbook Book in PDF, Epub and Kindle

"Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the FDA, "a combination product is one composed of any combination of a drug, a device, and a biological product. Examples include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components. This handbook provides the most up to date information on the development of combination products, from the technology involved to successful delivery. The authors present important and up to the minute pre and post market reviews of combination products as well as regulation"--

Medical Regulatory Affairs

Medical Regulatory Affairs
Title Medical Regulatory Affairs PDF eBook
Author Jack Wong
Publisher CRC Press
Pages 806
Release 2022-01-27
Genre Medical
ISBN 1000440516

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This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
Title Handbook of Stability Testing in Pharmaceutical Development PDF eBook
Author Kim Huynh-Ba
Publisher Springer Science & Business Media
Pages 389
Release 2008-11-16
Genre Medical
ISBN 0387856277

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This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Medical Devices Law and Regulation Answer Book

Medical Devices Law and Regulation Answer Book
Title Medical Devices Law and Regulation Answer Book PDF eBook
Author Suzan Onel
Publisher
Pages 0
Release 2022
Genre Medical instruments and apparatus
ISBN 9781402441622

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Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia
Title Handbook of Medical Device Regulatory Affairs in Asia PDF eBook
Author Jack Wong
Publisher CRC Press
Pages 618
Release 2013-03-27
Genre Medical
ISBN 9814411213

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Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.