Brody - FDA’s drug review process and the package label : strategies for writing successful FDA submissions

1. Tables in Chapter 1
2. Tables in Chapter 3
3. Tables in Chapter 4
4. Tables in Chapter 5
5. Tables in Chapter 6
6. Tables in Chapter 7
7. Tables in Chapter 8
8. Tables in Chapter 9
9. Tables in Chapter 10
10. Tables in Chapter 11
11. Tables in Chapter 12
12. Tables in Chapter 13
13. Tables in Chapter 14

1. Figures in Chapter 1
2. Figures in Chapter 3
3. Figures in Chapter 4
4. Figures in Chapter 5
5. Figures in Chapter 6
6. Figures in Chapter 7
7. Figures in Chapter 8
8. Figures in Chapter 9
9. Figures in Chapter 10
10. Figures in Chapter 11

Tom Brody

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To Dawnia and Shideh

The author received his PhD from the University of California at Berkeley in 1980, and conducted postdoctoral research at the University of Wisconsin-Madison and also at the University of California at Berkeley. The author has 15 years of pharmaceutical industry medical writing experience, acquired at Schering-Plough, Cerus Corporation, SciClone Pharmaceuticals, and Athena Neurosciences (Elan Pharmaceuticals), and has contributed to FDA submissions for the indications of multiple sclerosis, melanoma, head and neck cancer, hepatocellular carcinoma, idiopathic thrombocytopenic purpura, and hepatitis C virus. The author has published two editions of the textbook, Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. This book provides background information for the topics in the present book, but the information in these two books overlaps by only 5%.

The author has 15 years of training and experience in the Code of Federal Regulations as it applies to pharmaceuticals. Shortly before entering the pharmaceutical industry, he published two editions of Nutritional Biochemistry, which describes the clinical features, diagnosis, and treatment of metabolic diseases.