FDA Experience with Medical Countermeasures under the Animal Rule
Author
Source
Advances in Preventive Medicine
Issue
Vol. 2012, Issue 2012 (31 Dec. 2012), pp.1-11, 11 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2011-09-20
Country of Publication
Egypt
No. of Pages
11
Main Subjects
Abstract EN
The Food and Drug Administration issued a final rule in May 2002 to permit the Agency to approve drugs or license biological products on the basis of animal efficacy studies for use in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances.
Only two drugs were approved in the first nine years of the “Animal Rule” despite massive investment by the federal government since 2001 to stimulate development of medical countermeasures to biological threats.
This article therefore examines the Food and Drug Administration reviews made public after approval of those two drugs and the public discussion at the Agency's Anti-Infective Drugs Advisory Committee of one biological product under development under the Animal Rule.
Despite the paucity of approved drugs or licensed biological products as medical countermeasures, several investigational drugs have been placed in the National Strategic Stockpile for use as medical countermeasures, if needed.
American Psychological Association (APA)
Aebersold, Paul. 2011. FDA Experience with Medical Countermeasures under the Animal Rule. Advances in Preventive Medicine،Vol. 2012, no. 2012, pp.1-11.
https://search.emarefa.net/detail/BIM-477163
Modern Language Association (MLA)
Aebersold, Paul. FDA Experience with Medical Countermeasures under the Animal Rule. Advances in Preventive Medicine No. 2012 (2012), pp.1-11.
https://search.emarefa.net/detail/BIM-477163
American Medical Association (AMA)
Aebersold, Paul. FDA Experience with Medical Countermeasures under the Animal Rule. Advances in Preventive Medicine. 2011. Vol. 2012, no. 2012, pp.1-11.
https://search.emarefa.net/detail/BIM-477163
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-477163