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FDA to Run Pilots Designed to Reduce Total NDA Review Time

Executive Summary

Beginning in October, the FDA plans to test possible solutions designed to curtail multiple-cycle reviews--but it needs drug developers' help. The agency wants sponsors with fast-track product candidates to volunteer for two pilot programs--part of the Continuous Marketing Application (CMA) initiative--designed to assess both rolling application reviews and earlier, more frequent FDA-industry interactions.

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Shaking Up the FDA

To improve regulatory predictability, Mark McClellan has plans to reduce multiple-cycle reviews. In addition, he is in the midst of adopting best review practices and developing clearer guidances in therapeutic areas where progress has been slow and in certain emerging areas. While such plans potentially offer good news for the brand-name drug companies--though the benefits will be slow to accrue since the regulatory efficiencies will take years to fully materialize--they won't lower overall system costs since lower development expenses won't necessarily lead to lower average prices. Thus the FDA is focusing on two areas in which it has direct influence on drug costs and reimbursement: speeding the approval of generics and forcing OTC switches. McClellan's desire to impose a cost-benefit mindset on the agency attempts to balance the needs of the drug industry with the needs of reimbursers, particularly the Federal government as it prepares to shoulder the new burden of Medicare outpatient drug costs.

McClellan, Wall Street and Increasing FDA Predictability

The most encouraging aspect of the series of speeches the FDA's new commissioner, Mark McClellan, MD, PhD, has been giving is not what he says--we've heard most of this before--but to whom he says it: pharmaceutical investors and companies.

Pipeline Watch: Eight Approvals And Five Phase III Trial Updates

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.


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