Full Description
Modern Medicine: Biomedical Devices, Medical Gases, Radiopharmaceuticals, New Drug Discovery, Volume 2 discusses the procedures of drug approval and regulatory requirements that must be met according to the United States Food and Drug Administration (FDA), the European Medical Agency (EMA), and the Central Drug Standard Control Organization (CDSCO). In the rapidly evolving landscape of modern medicine, groundbreaking innovations have emerged that are reshaping the way we approach healthcare. Modern Medicine delves into the cutting-edge realms of medical devices, medical gases, radiopharmaceuticals, and new drug discovery, offering a comprehensive exploration of these transformative fields that are revolutionizing patient care and medical practices.
Discover the future of healthcare technology, and uncover the intricate world of biomedical engineering, where state-of-the-art devices seamlessly merge with the human body to monitor, diagnose, and treat ailments
Dive deep into the utilization of medical gases for respiratory conditions, pain management, and even novel applications in regenerative medicine
Unravel the mysteries of radiopharmaceuticals, a fusion of molecular imaging and therapy that offers unprecedented insights into the inner workings of the human body
Embark on a journey through the intricate processes of drug discovery, where groundbreaking research and cutting-edge technologies are yielding therapies that were once deemed impossible
Modern Medicine is a must-read for medical professionals, researchers, students, and anyone intrigued by the remarkable intersection of science, technology, and patient well-being. Join us on a journey to the forefront of medical innovation, where the unimaginable becomes reality, and the future of healthcare takes shape before our eyes. The chapter on regulatory implications for the approval process in this book will be the most useful resource for researchers and students, particularly those with backgrounds in pharma, forensic medicine, regulatory affairs, or those who aspire to succeed in drug research. Additionally, the information contained in this volume of the book could be of great interest to researchers working in the pharmaceutical and health industries.
Contents
New Drug or Investigational New Drug Applications (INDA) Approval Process with the Drugs and Cosmetics Act
Biomedical Device Rules and Enforcement
Schedule of Medical Device and Minimum Requirement of Approval
Approval and Registration Process of a Biomedical Device
Quality Assurance of Biomedical Devices Central Drugs Standard Control Organization (CDSCO), the United States Food and Drug Administration (US FDA) and the European Union (EU) Regulations
Regulation in Practising Telemedicine at the Edge of Data Confidentiality and Medical Ethics
Compressed Medical Gases: Regulations and Quality Control
Regulation of Radiopharmaceuticals in the Preview of the Drugs and Cosmetics Act, 1940
Abbreviated New Drug Application (ANDA) or Generic Drug Approval Process
Biological Licence Application (BLA) Procedures
Regulatory Approval of Biosimilars Including Nucleic Acid-based Recombinant Products, Recombinant Therapeutic Enzymes, and Protein
Regulations of Biopharmaceuticals Using Living Microorganisms, Genetically Modified Foods, and Vaccine Development
Role of Institutional Bio Safety Committee
Orphan Drugs and Regulatory Approval
Regulatory Approval Process of In Vitro Diagnostics
