Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.
Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.
Demonstrates how the FDA monitors and ensures pharmaceutical product safety and efficacy.
Offering critical information in every chapter, this guide
* Clarifies requirements for the preparation of product submissions in compliance with regulatory standards
* Details current efforts to streamline the regulatory process-including a specific example applicable to antibiotic products
* Covers the processes and issues related to the approval process for registration of prescription, generic, and over-the-counter drugs
* Considers patent issues, as well as the registration of pharmaceutical products
* Contains clinical research requirements for new drug applications
* Anticipates changes that may be required in the manufacturing process after the product application is approved
* Compares regulations for biological and pharmaceutical chemical products
Introduction to the Pharmaceutical Regulatory Process is must-have reading for all pharmaceutical engineers; pharmaceutical quality control and reliability managers; regulatory affairs professionals and attorneys; federal, state, and local officials responsible for compliance; and upper-level undergraduate and graduate students in these disciplines.
Contents
1. Legal
1. A HPharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act
2. New Drug Approval Process: Before and After 1962
3. FDA Regulation of Biological Products
4. Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs
5. Generic Drug Approval Process: Post 1984: Waxman-Hatch Reform
6. Food and Drug Administration Modernization Act
7. FDA's Antibiotic Regulatory Scheme: Then and Now
8. Pioneer and Generic Drugs: Balance Between Product Life Cycle
9. The Influence of the Prescription Drug User
Fee Act on the Approval Process
10. Clinical Research Requirements for New Drug Applications
2. FDA Requirements for Product Approvals and After
11. Active Pharmaceutical Ingredients
12. Obtaining Approval of a New Drug
13. Obtaining Approval of a Generic Drug
14. Current Good Manufacturing Practice and the Drug Approval Process
15. CMC Post-Approval Regulatory Affairs: Constantly Managing Change
16. The Influence of the USP on the Drug Approval Process
17. Ways and Means to U.S. Registration of Foreign Drugs
18. Common Technical Document-Quality (M4-Q): One Regulatory Participant's Perspective
19. 21 CFR Part 11: Compliance and Beyond
20. Marketing and Advertising Promotion: The Impact of Government Regulations
21. Approval and Marketing of Nonprescription or OTC Human Drugs
Download
Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.
Demonstrates how the FDA monitors and ensures pharmaceutical product safety and efficacy.
Offering critical information in every chapter, this guide
* Clarifies requirements for the preparation of product submissions in compliance with regulatory standards
* Details current efforts to streamline the regulatory process-including a specific example applicable to antibiotic products
* Covers the processes and issues related to the approval process for registration of prescription, generic, and over-the-counter drugs
* Considers patent issues, as well as the registration of pharmaceutical products
* Contains clinical research requirements for new drug applications
* Anticipates changes that may be required in the manufacturing process after the product application is approved
* Compares regulations for biological and pharmaceutical chemical products
Introduction to the Pharmaceutical Regulatory Process is must-have reading for all pharmaceutical engineers; pharmaceutical quality control and reliability managers; regulatory affairs professionals and attorneys; federal, state, and local officials responsible for compliance; and upper-level undergraduate and graduate students in these disciplines.
Contents
1. Legal
1. A HPharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act
2. New Drug Approval Process: Before and After 1962
3. FDA Regulation of Biological Products
4. Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs
5. Generic Drug Approval Process: Post 1984: Waxman-Hatch Reform
6. Food and Drug Administration Modernization Act
7. FDA's Antibiotic Regulatory Scheme: Then and Now
8. Pioneer and Generic Drugs: Balance Between Product Life Cycle
9. The Influence of the Prescription Drug User
Fee Act on the Approval Process
10. Clinical Research Requirements for New Drug Applications
2. FDA Requirements for Product Approvals and After
11. Active Pharmaceutical Ingredients
12. Obtaining Approval of a New Drug
13. Obtaining Approval of a Generic Drug
14. Current Good Manufacturing Practice and the Drug Approval Process
15. CMC Post-Approval Regulatory Affairs: Constantly Managing Change
16. The Influence of the USP on the Drug Approval Process
17. Ways and Means to U.S. Registration of Foreign Drugs
18. Common Technical Document-Quality (M4-Q): One Regulatory Participant's Perspective
19. 21 CFR Part 11: Compliance and Beyond
20. Marketing and Advertising Promotion: The Impact of Government Regulations
21. Approval and Marketing of Nonprescription or OTC Human Drugs
Download
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