Drug regulation history

Exhibit 7.2 presents a brief history of the FDA. For the purpose of regulation of drugs, the relevant centers are the CDER and CBER. 

BOX 4.8. HISTORY OF REGULATION GOVERNING DRUGS AND BIOLOGICS MARKETED IN THE UNITED STATES... 

A cursory examination of these definitions reveals that they are not mutually exclusive, leading to confusion about how to appropriately and consistently apply them. This point is illustrated when one reviews the history of how the FDA has categorized and subsequently regulated these drugs and biologies as shown below. 

Rago L, Santoso B (2008) Drug regulation history, present and future. In van Boxtel CJ, Santoso B, Edwards IR (eds) WHO drug benefits and risks international textbook of clinical pharmacology. IOS Press and Uppsala Monitoring Centre, Amsterdam... 

History of Drug Liability and Milestones in Drug Regulation.493... 

Sjunod, S.W., An alternative perspective homeopathic drugs. Royal Copeland, and federal drug regulation. Pharmacy in History, 42, 13, 2000, Available at www.homeowatch.org/his-tory/ reghx.html... 

Food and Drug Administration (1996). Regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents final rule. Fed Reg 61 44396 5318 Halliwell RF (2007) A short history of the rise of the molecular pharmacology of ionotropic drug receptors. Trends Pharmacol Sci 28(5) 214-219... 

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