The author wishes to express his gratitude to Mr. Nicholas Tantillo and Ms. Christine Mundkur for their invaluable assistance
and regulatory guidance.
Charles E. DiLiberti is vice president of scientific affairs at Barr Laboratories,Inc., 400 Chestnut Ridge Road,Woodcliff Lake, NJ,07677, firstname.lastname@example.org
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2. The Food Drug and Cosmetics Act. 1938 June 25.
3. The Food, Drug, and Cosmetics Act, 21 USC 321(g)(1) Definition of drug.
4. The Food, Drug and Cosmetic Act Section 505(b)(1).
5. The Food, Drug and Cosmetic Act Section 505(b)(2).
6. The Food, Drug and Cosmetic Act Section 505(j).
7. Public Health Service Act. Title 42 United States Code. Chapter 6.
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10. Code of Federal Regulations. Title 21—Food and Drugs. Chapter I Subchapter F — Biologics. Part 600 – Biological Products:
General. 21 CFR 600.3(h).
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14. EMEA Final Guidelines; Available at: