About the Book :
1. It is useful for pharmacy and law students.
2. The book describes the Food, Drug and Cosmetic Act, treats briefly regulations bearing on pharmaceutical mnaufacturing, looks at the structure, powers and duties of the Food and Drug Administration (FDA), describes state and local laws and regulations and covers the protection of industial property and product liability.
3. The Book contains lots of diagrammatic presentation to make laws easier to understand and memorise. Table of Contents :
PART I :
1 Schedule Y
2 Schedule M
3 Schedule T
4 Cosmetics and Consumers ,
PART II :
5 Good Clinical Practices
6 Good Laboratory Practices
7 Good Manufacturing Practices
8 USFDA , NDA , ANDA
9 Total Quality Management ,
PART III :
10 Intellectual Property Rights
11 Patent Act
12 Trademark Act
13 Copyright Act
14 Product Dossiers ,
PART IV :
15 Documentation and Maintenance of Records ,
PART V :
16 Pollution Control Act
17 The Environment Protection Act
18 Factory Act ,
PART VI :
19 Regulatory Requirements for Packing Materials
20 Drug Price Control Order
21. Product Development ,
22. Regulatory Requirements for Therapeutical, Medicinal and Biological Products,
23. ICH Guidelines,
24. Specifications of Clinical Trials
– Index
– Bibliography
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