Modern Medicine

Modern Medicine

Biomedical Devices, Medical Gases, Radiopharmaceuticals, New Drug Discovery, Volume 2

Goyary, Danswrang; Chattopadhyay, Pronobesh

Taylor & Francis Ltd

05/2024

352

Dura

Inglês

9781032503004

Pré-lançamento - envio 15 a 20 dias após a sua edição

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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
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Central licensing approval authority, Biomedical Device, Biological safety, Marketing surveillance, Diagnostic medical device, Drug categorization