ARTICLE | Regulation
New PDUFA clock starts
PDUFA V clock starts Oct. 1, gives FDA longer review times for NMEs
October 1, 2012 7:00 AM UTC
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...