ARTICLE | Regulation
No laws needed
Pharma scientists recommend new antibiotics regulatory framework
January 28, 2013 8:00 AM UTC
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...