Project Bioshield Act
The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.
primaryTopic
Project Bioshield Act
The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. This was a ten-year program to acquire medical countermeasures to biological, chemical, radiological, and nuclear agents for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns. Efficacy of such agents cannot be directly tested in humans without also exposing humans to the chemical, biological, or radioactive threat being treated, so testing follows the FDA Animal Rule for pivotal animal efficacy.
has abstract
The Project Bioshield Act was ...... ction are part of the project.
@en
Link from a Wikipage to an external page
Wikipage page ID
12,787,297
Wikipage revision ID
742,701,267
cite public law
cite statutes at large
enacted by
Fullname
An Act To amend the Public Hea ...... val process of countermeasures
introducedby
introduceddate
2003-03-11
introducedin
leghisturl
name
Project BioShield Act of 2004
passedbody
passeddate
2004-05-19
2004-07-14
public law url
sections amended
Chapter 6A § 201
signeddate
2004-07-21
signedpresident
title amended
subject
hypernym
type
comment
The Project Bioshield Act was ...... e for pivotal animal efficacy.
@en
label
Project Bioshield Act
@en