Navigating the FDA Regulatory Processes
portes grátis
Navigating the FDA Regulatory Processes
An Integrated Clinical and Engineering Approach
Elman, Noel; Gurman, Pablo; Rosen, Yitzhak
Taylor & Francis Inc
01/2025
296
Dura
Inglês
9781482207088
Pré-lançamento - envio 15 a 20 dias após a sua edição
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Chapter 1- Introduction
Chapter 2- Dancing with the FDA: Managing Expectations
Chapter 3- New Drug Application
Chapter 4- Basics of Generic Drug Regulation
Chapter 5- Introduction to Medical Device Regulation
Chapter 6- FDA and Regulation of Biologics
Chapter 7- Combination Products
Chapter 8- FDA Expedited Pathways
Chapter 9- Investigator-Initiated Sponsored Research
Chapter 10- Medical Countermeasures for Public Health Emergency Preparedness and Response in The United States: A Regulatory Perspective
Chapter 2- Dancing with the FDA: Managing Expectations
Chapter 3- New Drug Application
Chapter 4- Basics of Generic Drug Regulation
Chapter 5- Introduction to Medical Device Regulation
Chapter 6- FDA and Regulation of Biologics
Chapter 7- Combination Products
Chapter 8- FDA Expedited Pathways
Chapter 9- Investigator-Initiated Sponsored Research
Chapter 10- Medical Countermeasures for Public Health Emergency Preparedness and Response in The United States: A Regulatory Perspective
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Introduction: Overview of the FDA;PART 2: Clinical Considerations;PART 3: Technological Considerations;PART 4: Industry and Business Considerations;PART 5: Appendix and FDA Reference for Cleared Biomedical and Biomaterials
Chapter 1- Introduction
Chapter 2- Dancing with the FDA: Managing Expectations
Chapter 3- New Drug Application
Chapter 4- Basics of Generic Drug Regulation
Chapter 5- Introduction to Medical Device Regulation
Chapter 6- FDA and Regulation of Biologics
Chapter 7- Combination Products
Chapter 8- FDA Expedited Pathways
Chapter 9- Investigator-Initiated Sponsored Research
Chapter 10- Medical Countermeasures for Public Health Emergency Preparedness and Response in The United States: A Regulatory Perspective
Chapter 2- Dancing with the FDA: Managing Expectations
Chapter 3- New Drug Application
Chapter 4- Basics of Generic Drug Regulation
Chapter 5- Introduction to Medical Device Regulation
Chapter 6- FDA and Regulation of Biologics
Chapter 7- Combination Products
Chapter 8- FDA Expedited Pathways
Chapter 9- Investigator-Initiated Sponsored Research
Chapter 10- Medical Countermeasures for Public Health Emergency Preparedness and Response in The United States: A Regulatory Perspective
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
