Product Code Database
UPDATE: S. 3187, the Food and Drug Administration Safety and Innovation Act, scheduled for <br /> floor consideration, is an amended version of S. 2516, reported by the Senate Committee on <br /> Health, Education, Labor, and Pensions. The House Committee on Energy and Commerce voted <br /> favorably to report H.R. 5651, the Food and Drug Administration Reform Act of 2012. Both the <br /> Senate and House bills include titles to reauthorize FDA prescription drug and medical device <br /> user fee programs, authorize new user fee programs for generic drugs and biosimilar biological <br /> products, and amend the Federal Food, Drug, and Cosmetic Act regarding the regulation of <br /> drugs and medical devices. (Note: The rest of this report has not been updated since September 1, <br /> 2011.) <br /> The Food and Drug Administration (FDA) is a regulatory agency within the Department of <br /> Health and Human Services. A key responsibility is to regulate the safety and effectiveness of <br /> drugs sold in the United States. FDA divides that responsibility into two phases: preapproval <br /> (premarket) and postapproval (postmarket). FDA reviews manufacturers' applications to market <br /> drugs in the United States; a drug may not be sold unless it has FDA approval. The agency <br /> continues its oversight of drug safety and effectiveness as long as the drug is on the market. <br /> Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and <br /> expanded FDA's responsibilities regarding drug approval and regulation.
References
^ Crs Report For Congress: How Fda Approves Drugs And Regulates Their Safety And Effectiveness Indigo. ISBN 9781295273966 (revised Dec 2015)
|
