|
" Challenges for the FDA : "
Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs.
| Document Type
|
:
|
BL
|
| Record Number
|
:
|
1033157
|
| Doc. No
|
:
|
b787527
|
| Main Entry
|
:
|
Symposium on the Future of Drug Safety: Challenges for the FDA(2007 :, Washington, D.C.)
|
| Title & Author
|
:
|
Challenges for the FDA : : the Future of Drug Safety : Workshop Summary /\ Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs.
|
| Publication Statement
|
:
|
Washington, DC :: National Academies Press,, ©2007.
|
| Page. NO
|
:
|
1 online resource (xvii, 109 pages) :: illustrations
|
| ISBN
|
:
|
0309109876
|
|
|
:
|
: 1281093556
|
|
|
:
|
: 6611093559
|
|
|
:
|
: 9780309109871
|
|
|
:
|
: 9781281093554
|
|
|
:
|
: 9786611093556
|
|
|
:
|
0309109868
|
|
|
:
|
9780309109864
|
| Bibliographies/Indexes
|
:
|
Includes bibliographical references (pages 78-79).
|
| Contents
|
:
|
Addressing the FDA's Resource Challenges -- Strengthening the Scientific Base of the Agency -- Integrating Pre- and Postmarket Review -- Enhancing Postmarket Safety Monitoring -- Conducting Confirmatory Drug Safety and Efficacy Studies -- Enhancing the Value of Clinical Trial Registration -- Enhancing Postmarket Regulation and Enforcement -- Looking to the Future.
|
| Subject
|
:
|
United States.-- Rules and practice.
|
|
|
:
|
United States
|
|
|
:
|
United States-- rules practice
|
|
|
:
|
United States.
|
| Subject
|
:
|
Drugs-- United States-- Safety measures, Congresses.
|
| Subject
|
:
|
Drugs-- United States-- Testing, Congresses.
|
| Subject
|
:
|
Drug Approval.
|
| Subject
|
:
|
United States Food and Drug Administration
|
| Subject
|
:
|
Drugs-- Safety measures.
|
| Subject
|
:
|
Drugs-- Testing.
|
| Subject
|
:
|
MEDICAL-- Drug Guides.
|
| Subject
|
:
|
MEDICAL-- Nursing-- Pharmacology.
|
| Subject
|
:
|
MEDICAL-- Pharmacology.
|
| Subject
|
:
|
MEDICAL-- Pharmacy.
|
| Subject
|
:
|
Drug Approval-- organization administration.
|
| Subject
|
:
|
Drug Approval.
|
| Subject
|
:
|
Drug-Related Side Effects and Adverse Reactions-- prevention control.
|
| Subject
|
:
|
Drug-Related Side Effects and Adverse Reactions.
|
| Subject
|
:
|
Safety.
|
| Subject
|
:
|
Adverse Drug Reaction Reporting Systems-- organization administration.
|
| Subject
|
:
|
Drug Evaluation, Preclinical-- standards.
|
| Subject
|
:
|
Drug Interactions.
|
| Subject
|
:
|
Drug-Related Side Effects and Adverse Reactions.
|
| Subject
|
:
|
Government Agencies.
|
| Subject
|
:
|
Product Surveillance, Postmarketing-- standards.
|
| Subject
|
:
|
Product Surveillance, Postmarketing.
|
| Subject
|
:
|
United States.
|
| Subject
|
:
|
United States.
|
| Dewey Classification
|
:
|
615/.19
|
| LC Classification
|
:
|
RM301.27.S96 2007eb
|
| NLM classification
|
:
|
2007 L-855
|
|
|
:
|
QV 771S9889c 2007
|
| Added Entry
|
:
|
Pray, Leslie A.
|
|
|
:
|
Robinson, Sally.
|
| Added Entry
|
:
|
Institute of Medicine (U.S.)., Forum on Drug Discovery, Development, and Translation.
|
| |