REGULATORY STRATEGIES FOR THE APPROVAL OF COMBINATION PRODUCTS

The primary objective of this book is to comprehensively evaluate the design, development, Regulatory considerations, and clinical implications of combination products in the healthcare industry. Through an in-depth analysis of existing literature, case studies, and regulatory frameworks, this research aims to identify key challenges and opportunities associated with the integration of different therapeutic modalities or medical technologies into a single product. Furthermore, this book seeks to propose practical guidelines and recommendations for optimizing the development and regulatory process of combination products, with a focus on ensuring efficacy, safety, and successful market introduction. By achieving these objectives, this research contributes valuable insights to the evolving landscape of combination products, facilitating informed decision-making among industry stakeholders and regulatory bodies.

Autorentext

Ms. Mydelli Nollu has been working as a Client Service Associate in one of the prestigious company ICON Clinical Research Limited. She has completed her Masters of Pharmacy in the department of Drug Regulatory Affairs from an esteemed State University named Andhra University.