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An overview of FDA regulated products : from drugs and cosmetics to food and tobacco /
Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valu...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London :
Academic Press,
[2018]
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Cover; Title page; Copyright page; Dedication; Contents; Contributors; Foreword; Preface; Acknowledgments; Chapter 1
- Introduction to FDA-regulated products; Chapter objectives; 1.1
- What is a regulated product?; 1.2
- How are different products regulated?; 1.3
- Product classification; 1.4
- History of the modern regulatory system; 1.4.1
- Adulteration and misbranding; 1.4.2
- Safety; 1.4.3
- Efficacy; 1.4.4
- Regulation of medical devices; 1.4.5
- User fees; 1.5
- Focus on postmarketing oversight; 1.6
- The modern regulatory system; References
- Chapter 2
- Regulatory agencies of the ICH: authorities, structures, and functionsChapter objectives; 2.1
- Introduction; 2.2
- United states of america: food and drug administration; 2.2.1
- Establishing a regulatory mechanism; 2.2.2
- What is fda's mission?; 2.2.3
- How is the fda structured?; 2.2.4
- Medical products; 2.2.5
- Legal framework; 2.2.6
- Fda's functions; 2.2.6.1
- Permitting unapproved products to undergo testing in humans; 2.2.6.2
- Reviewing applications for marketing; 2.2.6.2.1
- Drugs; 2.2.6.2.2
- Biologics; 2.2.6.2.3
- Medical devices; 2.2.6.3
- Pharmacovigilance
- 2.2.7
- OTHER PRODUCTS2.2.7.1
- Veterinary products; 2.2.7.2
- Food; 2.2.7.3
- Cosmetics; 2.2.7.4
- Tobacco products; 2.3
- JAPAN: PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA); 2.3.1
- MISSION; 2.3.1.1
- Reviews; 2.3.1.2
- Safety measures; 2.3.1.3
- Relief services for patients suffering from adverse health effects; 2.3.2
- SCOPE; 2.3.3
- ORGANIZATION STRUCTURE; 2.3.4
- PRIMARY REGULATORY FUNCTIONS; 2.3.5
- NOTEWORTHY REGULATORY PROVISIONS; 2.3.5.1
- Special regulatory pathway for regenerative medicine; 2.3.5.2
- Drug master file system
- 2.3.5.3
- Accelerated regulatory pathway for innovative products2.3.5.4
- Accredited foreign manufacturer; 2.3.6
- MEDICAL DEVICES; 2.3.7
- QUASIDRUGS; 2.3.8
- COSMETICS; 2.3.9
- ORPHAN PRODUCTS; 2.3.10
- POSTMARKETING SAFETY MEASURE; 2.3.10.1
- Early postmarketing phase vigilance; 2.3.10.2
- Mihari project; 2.3.10.3
- Relief services for adverse health effects; 2.3.11
- REGULATORY SCIENCE; 2.3.12
- INTERNATIONAL ACTIVITIES; 2.3.13
- SUMMARY; 2.4
- EUROPEAN UNION: EUROPEAN MEDICINES AGENCY; 2.4.1
- MISSION AND SCOPE; 2.4.2
- LEGAL FRAMEWORK; 2.4.3
- CENTRALIZED PROCEDURE
- 2.4.3.1
- Biotechnology products2.4.3.2
- Advanced therapies; 2.4.3.3
- Selected indications; 2.4.4
- CLINICAL TRIALS; 2.4.4.1
- Investigational medicinal product application; 2.4.5
- MEDICAL DEVICES; 2.4.6
- PHARMACOVIGILANCE; 2.4.6.1
- Risk management plan (EMA, 2016m); 2.4.6.2
- Qualified person of pharmacovigilance (QPPV); 2.4.7
- SUMMARY; 2.5
- ROLE OF CIOMS AND ICH; 2.5.1
- CIOMS; 2.5.2
- ICH; 2.6
- OVERALL SUMMARY; References; Further ReadingS; Chapter 3
- Drugs; Chapter Objectives; 3.1
- Is the product a drug?; 3.2
- How are drugs categorized?
- 3.3
- What is a regulatory strategy and what does it entail?