ROLE OF THE FDA’S DRUG REGISTRATION PROCESS IN THE USA

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DOI: https://doi.org/None
Issue: 
3
Year: 
2015

T.V. Kartavtsova (1); Professor D.M. Andreeva (2*), PhD; G.N. Gildeeva, PhD 1 -Department for Governmental Regulation of Drug Circulation, Ministry of Health of Russia, Moscow; 3, Rakhmanovsky Pereulok, Moscow 127994 2 -I.M. Sechenov First Moscow State Medical University; 8, Trubetskaya St., Build. 2, Moscow 119991

The paper provides the review of the experience of the Food and Drug Administration (FDA), which is associated with the expert examination and regulation of drug circulation in the USA. It considers the FDA’s organizational and functional structure, the sequence of actions required for the USA registration of a drug, its approval by the FDA, and its entrance into the pharmaceutical market. Some stages of a registration process are analyzed; the characteristic features of each stage have been found.
Keywords: 
Food and Drug Administration (FDA)
legal status
preclinical trials
clinical trials
entrance into the market
References: 
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