Modern Medicine: Biomedical Devices, Medical Gases, Radiopharmaceuticals, New Drug Discovery, Volume 2 [Hardcover]

1. New Drug or Investigational New Drug Applications (INDA) Approval Process with the Drugs and Cosmetics Act
2. Biomedical Device Rules and Enforcement
3. Schedule of Medical Device and Minimum Requirement of Approval
4. Approval and Registration Process of a Biomedical Device
5. 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
6. Regulation in Practising Telemedicine at the Edge of Data Confidentiality and Medical Ethics
7. Compressed Medical Gases: Regulations and Quality Control
8. Regulation of Radiopharmaceuticals in the Preview of the Drugs and Cosmetics Act, 1940
9. Abbreviated New Drug Application (ANDA) or Generic Drug Approval Process
10. Biological Licence Application (BLA) Procedures
11. Regulatory Approval of Biosimilars Including Nucleic Acid-based Recombinant Products, Recombinant Therapeutic Enzymes, and Protein
12. Regulations of Biopharmaceuticals Using Living Microorganisms, Genetically Modified Foods, and Vaccine Development
13. Role of Institutional Bio Safety Committee
14. Orphan Drugs and Regulatory Approval
15. Regulatory Approval Process of In Vitro Diagnostics

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 ml³<