promoting and protecting the health of the public /
First Statement of Responsibility
Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies ; Alina Baciu, Kathleen Stratton, Sheila P. Burke, editors.
Introduction -- Natural history of a drug -- A culture of safety -- The science of safety -- Regulatory authorities for drug safety -- Communicating about safety -- Resources for the drug safety system.
0
SUMMARY OR ABSTRACT
Text of Note
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' risk benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
OTHER EDITION IN ANOTHER MEDIUM
Title
Future of drug safety.
International Standard Book Number
9780309103046
CORPORATE BODY NAME USED AS SUBJECT
United States.
United States.
United States.
TOPICAL NAME USED AS SUBJECT
Drugs-- United States-- Safety measures.
Pharmaceutical policy-- United States.
Drug Approval-- United States.
United States Government Agencies-- United States.
Drugs-- Safety measures.
Pharmaceutical policy.
POLITICAL SCIENCE-- Public Policy-- Social Security.
POLITICAL SCIENCE-- Public Policy-- Social Services & Welfare.
GEOGRAPHICAL NAME USED AS SUBJECT
United States.
7
(SUBJECT CATEGORY (Provisional
K
POL-- 019000
POL-- 027000
DEWEY DECIMAL CLASSIFICATION
Number
362
.
17/82
Edition
22
LIBRARY OF CONGRESS CLASSIFICATION
Class number
RA401
.
A3
Book number
.
I568
2007eb
OTHER CLASS NUMBERS
Class number
QV
771
Book Number
I5852f
2007
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
Baciu, Alina.
Burke, Sheila P.
Stratton, Kathleen R.
CORPORATE BODY NAME - PRIMARY RESPONSIBILITY
Institute of Medicine (U.S.)., Committee on the Assessment of the US Drug Safety System.