Saturday, 21 April 2018

Pharmaceutics book: FDA Regulatory Affairs

Subject: Pharmaceutics

Book Name: FDA  Regulatory Affairs
Publication: Informa Healthcare
Page: 466
Content:
1. Overview of FDA and Drug Development .. . . 1
2. What Is an IND? . . . . 33
3. The New Drug Application .. . . 69
4. Meeting with the FDA .. . . 109
5. FDA Medical Device Regulation . . . . 125
6. The Development of Orphan Drugs .. . . 167
7. CMC Sections of Regulatory Filings and CMC Regulatory Compliance During Investigational and Postapproval Stages . . .  . . 187
8. Overview of the GxPs for the Regulatory Professional . . . 213
9. FDA Regulation of the Advertising and Promotion of Prescription Drugs, Biologics, and Medical Devices . . 267
10. Electronic Submissions—A Guide for Electronic Regulatory Submissions to FDA . . . 289
11. The Practice of Regulatory Affairs . . . 351
12. A Primer of Drug/Device Law: What’s the Law and How Do I find It? . . .. 369
13. FDA Advisory Committees . . . . 397
14. Biologics . . . . 417

Click here for view the book