Monday, October 1, 2012
On Monday this week, FDA and
industry will launch an experiment designed to test the hypothesis that a
longer, more interactive review process will make drug regulation more
predictable and efficient.
Oct. 1, the first day of the
fiscal year, marks the beginning of a new set of rules governing the review of
applications to market new molecular entities. PDUFA goals for reviews of new
drugs and biologics will be extended by two months as a result of a mandatory "filing
period" tacked onto the beginning of the review cycle.