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12:00 AM
Feb 13, 2006
 |  BioCentury  |  Politics, Policy & Law

Multicycles or unicycles?

While the regulatory period preceding submission of an NDA or BLA is the most promising target for dramatically speeding drug development, there still are opportunities to reduce the time FDA takes to review and approve drugs. The biggest opportunity is to reduce the number of review cycles an application goes through.

The Prescription Drug User Fee Act establishes deadlines for acting on an NDA and BLA of 10 months for a standard application and six months for a priority application. The deadlines can be extended by three months if a sponsor makes a major amendment within three months of the review deadline.

PDUFA also gives the agency an alternative to either missing a deadline or issuing a rejection if an application has deficiencies. FDA can inform a sponsor of deficiencies and describe steps to overcome them. A sponsor's resubmission starts a second review cycle. The target for reviewing resubmissions for relatively minor deficiencies (designated as "class 1") is two months, and is six months for more substantial "class 2" resubmissions.

During negotiations for PDUFA III, FDA said efforts to meet requirements imposed under PDUFA II had stretched its resources, leaving reviewers too little time to resolve problems with standard applications in a single review. "As a result, the application must undergo an additional...

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