Combination Products Handbook: The Ultimate Guide to Developing and Delivering Successful Therapeutic and Diagnostic Products

By Susan Neadle

Combination products are revolutionizing the healthcare industry by providing innovative solutions that combine drugs, devices, and biological products. These cutting-edge products not only enhance the effectiveness of medical treatments but also improve patient convenience and treatment outcomes. The “Combination Products Handbook” by Susan Neadle is a comprehensive guide that offers valuable insights into the development, regulations, and successful delivery of these groundbreaking therapeutic and diagnostic products.

In this handbook, Neadle and her team of experts provide a wealth of information on the technology behind combination products and guide readers through every step of the product development lifecycle. From pre-market considerations to post-market reviews, this handbook covers the latest guidance, regulations, and best practices in the field of combination products.

One of the unique features of the “Combination Products Handbook” is its global perspective. The authors not only review the current state-of-the-art practices followed in the United States but also provide insights into international combination product regulations. This global perspective is essential for companies looking to navigate the complex landscape of international regulatory authorities and ensure compliance with various guidelines.

The book begins by defining combination products according to the US Food and Drug Administration (FDA). It explains that a combination product can be a composition of a drug and a device, a biological product and a device, a drug and a biological product, or a combination of all three. The handbook then dives into specific examples of combination products, such as 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. These examples help readers understand the diverse range of products that fall under the combination products category.

Throughout the book, Neadle emphasizes the importance of regulatory compliance in the development and commercialization of combination products. The authors provide detailed insights into medical product classification and assignment issues faced by global regulatory authorities and the industry. This information helps companies streamline their regulatory processes, navigate potential challenges, and maximize the chances of successful product approvals.

The “Combination Products Handbook” also discusses the crucial aspects of product marketing and commercialization. It provides insights into the market dynamics, competition, and consumer preferences related to combination products. By highlighting the best practices in marketing and launching combination products, the authors empower companies with the knowledge and strategies required to establish a strong market presence and drive sales.

As an internationally recognized Combination Products and Medical Device expert with over 35 years of industry experience, Susan Neadle brings a wealth of knowledge and practical insights to this handbook. Her team of contributors comprises experts from various fields, adding to the depth and breadth of the information presented. The “Combination Products Handbook” is endorsed by the Association for the Advancement of Medical Instrumentation (AAMI), further validating its credibility and relevance in the healthcare industry.

With its comprehensive coverage of global combination product regulations, the latest industry insights, and practical guidance, the “Combination Products Handbook” is an indispensable resource for professionals involved in the development, regulatory compliance, and commercialization of combination products. Whether you are a pharmaceutical company seeking to expand your product offerings or a regulatory authority aiming to ensure patient safety, this handbook is an essential addition to your reference library.

About the Author

Susan Neadle is a highly accomplished Combination Products and Medical Device expert with over 35 years of industry experience. She has been instrumental in guiding numerous companies through the complex regulatory landscape and has an in-depth understanding of the challenges and opportunities associated with developing combination products. Neadle’s expertise and practical insights make her an authoritative figure in the field, and her contributions to the “Combination Products Handbook” are invaluable for both industry professionals and regulatory authorities.

Product Details

• Publisher: CRC Press; 1st edition (May 16, 2023)
• Language: English
• eBook Digital: 592 pages
• ISBN-10: 1032291621
• ISBN-13: 978-1032291628