Books > Social sciences > Politics & government
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Crs Report for Congress - How FDA Approves Drugs and Regulates Their Safety and Effectiveness (Paperback)
Loot Price: R383
Discovery Miles 3 830
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Crs Report for Congress - How FDA Approves Drugs and Regulates Their Safety and Effectiveness (Paperback)
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Loot Price R383
Discovery Miles 3 830
Expected to ship within 10 - 15 working days
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UPDATE: S. 3187, the Food and Drug Administration Safety and
Innovation Act, scheduled for floor consideration, is an amended
version of S. 2516, reported by the Senate Committee on Health,
Education, Labor, and Pensions. The House Committee on Energy and
Commerce voted favorably to report H.R. 5651, the Food and Drug
Administration Reform Act of 2012. Both the Senate and House bills
include titles to reauthorize FDA prescription drug and medical
device user fee programs, authorize new user fee programs for
generic drugs and biosimilar biological products, and amend the
Federal Food, Drug, and Cosmetic Act regarding the regulation of
drugs and medical devices. (Note: The rest of this report has not
been updated since September 1, 2011.) The Food and Drug
Administration (FDA) is a regulatory agency within the Department
of Health and Human Services. A key responsibility is to regulate
the safety and effectiveness of drugs sold in the United States.
FDA divides that responsibility into two phases: preapproval
(premarket) and postapproval (postmarket). FDA reviews
manufacturers' applications to market drugs in the United States; 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 FDA's
responsibilities regarding drug approval and regulation.
General
Imprint: |
Bibliogov
|
Country of origin: |
United States |
Release date: |
November 2013 |
First published: |
November 2013 |
Authors: |
Susan Thaul
|
Dimensions: |
246 x 189 x 1mm (L x W x T) |
Format: |
Paperback - Trade
|
Pages: |
26 |
ISBN-13: |
978-1-295-27396-6 |
Categories: |
Books >
Social sciences >
Politics & government >
General
|
LSN: |
1-295-27396-9 |
Barcode: |
9781295273966 |
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