Project BioShield and FDA drug rules

[JURIST] The White House Monday posted a fact sheet on Project BioShield [White House fact sheet], President Bush's initiative announced in the State of the Union Address "to develop and make available modern, effective drugs and vaccines to protect against attack by biological and chemical weapons or other dangerous pathogens." Part of the Project involves development of an FDA Emergency Use Authorization which would allow "access to a potentially beneficial treatment in an emergency situation, when it is most likely to save lives, even if it has not yet been proven to be suitable for routine general use or has not completed the formal process for full FDA licensure."



 

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