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Oct 01, 2012
 |  BioCentury  |  Regulation

New PDUFA clock starts

PDUFA V clock starts Oct. 1, gives FDA longer review times for NMEs

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.

The additional two months, the result of a deal BIO and PhRMA struck with FDA during PDUFA V negotiations, are part of a revamp of the approval process that is intended to enhance communication between reviewers and sponsors.

PDUFA V changed the review process in ways that are intended to give sponsors opportunities to make mid-course corrections while an application is under review, and to prevent last-minute surprises. One of the biggest changes will be earlier disclosure of the issues FDA plans to raise at advisory committee meetings.

In addition to changing review processes and timelines, PDUFA V and the FDA Safety and Innovation Act (FDASIA) created a new biosimilar user fee that must be paid as soon as a sponsor submits an IND for a biosimilar or meets with FDA to discuss development of one.

Although the biosimilar user fee was not included in a temporary budget bill covering the first half of FY13, FDASIA gives FDA authority to collect and spend biosimilar user fees, agency spokesperson Chris Kelly told BioCentury last week.

Other PDUFA V and FDASIA provisions that go into effect on Oct. 1 include...

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