Combination Products: Regulatory Challenges and Successful Product Development

✍ Scribed by Smita Gopalaswamy, Venky Gopalaswamy

Publisher: CRC Press
Year: 2008
Tongue: English
Leaves: 260
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

The field of combination product development is so new that very few publications, including FDA documents, are available. This text provides an overview of the process from start to finish, complete with relevant definitions, and then shows how to establish a design and development plan. It provides an overview of FDA and other regulatory expectations and covers resource requirements, manufacturing, pitfalls, post-launch compliance requirements, and agency audits and challenges. The book presents practical guidelines on how to develop combination products successfully and how to implement these products into the market successfully and in a timely manner.

📜 SIMILAR VOLUMES

Combination Products: Regulatory Challen

📁 Combination Products: Regulatory Challenges and Successful Product Development

✍ Smita Gopalaswamy, Venky Gopalaswamy 📂 Library 📅 2008 🏛 CRC Press 🌐 English

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by t

Combination Products: Regulatory Challen

📁 Combination Products: Regulatory Challenges and Successful Product Development

✍ Smita Gopalaswamy (Author); Venky Gopalaswamy (Author) 📂 Library 📅 2011 🏛 CRC Press

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed b

Development and Approval of Combination

📁 Development and Approval of Combination Products: A Regulatory Perspective

✍ Evan B. Siegel 📂 Library 📅 2008 🌐 English

A step-by-step, integrated approach for successful, FDA-approved combination drug productsUsing a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective,

Development and Approval of Combination

📁 Development and Approval of Combination Products: A Regulatory Perspective

📂 Library 📅 2008 🌐 English

A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory per

Powerful Products: Strategic Management

📁 Powerful Products: Strategic Management of Successful New Product Development

✍ Roger Bean, Russell Radford 📂 Library 📅 2000 🌐 English

"Faster, cheaper, better." That's been the mantra of business for decades--in just that order--with the "better" part all but obliterated by "faster and cheaper." According to authors Bean and Radford, it's time for manufacturers to put the emphasis on the "better"--because it's better products,

Creative Design and Innovation: How to P

📁 Creative Design and Innovation: How to Produce Successful Products and Buildings

✍ Robin Roy 📂 Library 📅 2024 🏛 Routledge 🌐 English

Using many real-world examples and cases, this book identifies key factors and processes that have contributed to the creation of successful new products, buildings, and innovations, or resulted in some failures. Such factors include the creativity of individuals and groups, their sources o