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Senate to consider new FDA approval paths
November 12, 2011 1:26 AM UTC
A draft of legislation produced by Sen. Kay Hagan (D-N.C.) seeks to create two new FDA approval pathways. Drugs would be eligible for "progressive" or "exceptional" approval if they are intended to provide meaningful advances in the treatment of an unmet serious or life threatening condition, according to a copy of the bill obtained by BioCentury. FDA could also approve drugs based on approval in the EU as well as in Australia, Canada and some other countries. ...