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Cover Story
Pharma scientists recommend new antibiotics regulatory framework
No laws needed
By Steve Usdin
Washington Editor
Published on
Monday, January 28, 2013
The Infectious
Diseases Society of America is lobbying Congress to pass legislation
creating a limited-use approval pathway to pave the way for new antibiotics,
but scientists from seven antibiotics developers say FDA and EMA could get the
job done using existing laws and regulations.
IDSA's proposed limited
population antibacterial drug (LPAD) approval mechanism is intended to make FDA
comfortable approving new antibiotics based on limited data. It includes
provisions designed to prevent widespread use - and abuse - of drugs that are
targeted at specific types of infections.
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