How the Food and Drug Administration (FDA) Approves Drugs and Regulates Their Safety and Effectiveness

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By Susan Thaul (au)
Year: 2012
Pages: 23
Binding Paperback
ISBN 978-1-4578-3292-5

Product Code: 1457832925

Description

The Food and Drug Admin. (FDA) is a regulatory agency within the Dept. of Health and Human Services (HHS). A key responsibility is to regulate the safety and effectiveness of drugs sold in the U.S. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturersäó» applications to market drugs in the U.S.; a drug may not be sold unless it has FDA approval. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and expanded FDAäó»s responsibilities regarding drug approval and regulation. Contents of this report: Legislative History of Drug Regulation; How FDA Approves New Drugs; How FDA Regulates Approved Drugs. Figures and tables. This is a print on demand report.

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